Engineering Structures Jobs in Fremont Ca Remote

625 positions found — Page 30

Water/Wastewater Estimator
Salary not disclosed
Fremont, California 1 week ago

Position Overview

The Water/Wastewater Estimator will be responsible for preparing accurate and competitive cost estimates for heavy civil infrastructure projects. This role requires strong analytical skills, in-depth knowledge of water and wastewater construction, and the ability to collaborate effectively with project managers, engineers, subcontractors, and suppliers.

Key Responsibilities

  • Analyze plans, specifications, geotechnical reports, and contract documents for water and wastewater infrastructure projects
  • Prepare detailed quantity takeoffs and cost estimates for treatment plants, pipelines, pump stations, and related facilities
  • Solicit and evaluate subcontractor and supplier quotes
  • Develop conceptual and hard-bid estimates
  • Identify project risks and value engineering opportunities
  • Participate in pre-bid meetings and site visits
  • Maintain organized bid documentation and estimating databases
  • Support project handoff to operations team upon award

Qualifications

  • 5+ years of estimating experience in water/wastewater or heavy civil construction
  • Strong knowledge of treatment plant construction, underground utilities, mechanical piping, and concrete structures
  • Proficiency with estimating software (e.g., HCSS HeavyBid, Bluebeam, PlanSwift, or similar)
  • Ability to read and interpret civil, structural, and mechanical drawings
  • Strong Excel skills
  • Excellent communication and organizational abilities
  • Bachelor's degree in Construction Management, Civil Engineering, or related field preferred (or equivalent experience)

What We Offer

  • Competitive salary based on experience
  • Performance-based bonus opportunities
  • Comprehensive health, dental, and vision insurance
  • 401(k) with company match
  • Paid time off and holidays
  • Career growth opportunities within a rapidly expanding infrastructure market
Not Specified
Head of Legal/General Counsel @ Mission Driven SaaS Company
Salary not disclosed
Fremont, California 1 week ago

Overview

Whistler Partners is partnering with to hire its first senior legal leader — a Head of Legal with the opportunity to step into a General Counsel title for the right candidate.

Owner provides a suite of tools designed to help local restaurant owners increase sales and strengthen their online presence. From mobile ordering and customer rewards to digital growth infrastructure, the platform empowers independent restaurants to compete and win. As the business expands product surfaces, navigates regulatory complexity, and enters increasingly strategic partnerships, legal leadership is now mission-critical.

This is a foundational hire at a high-growth, mission-driven SaaS company.

Why this role?

This is not an incremental legal hire. It's a build-from-zero seat.

You will own the full legal stack — corporate, compliance, employment, IP, litigation, regulatory, and commercial — and serve as a strategic partner to the executive team. You won't inherit a pre-built function. You'll architect it.

Success in this role means:

  • Building scalable systems from ambiguity
  • Knowing when to leverage outside counsel — and when to move internally
  • Acting as DRI on the company's most sensitive initiatives
  • Helping leadership move faster while strengthening risk discipline

The title is flexible and may include General Counsel for the right candidate.

This is ideal for a builder who wants true ownership, executive visibility, and the opportunity to shape Legal at a scaling technology company from day one.

Key Responsibilities

  • Partner closely with Engineering, Product & Design, GTM, People, Finance, Ops, and the Executive team
  • Act as strategic advisor to the CEO on negotiations, disputes, and sensitive matters
  • Build and scale Owner's Legal function as its first full-time legal hire
  • Serve as DRI on litigation strategy, regulatory posture, and complex commercial agreements
  • Partner with Product and Engineering to ensure new products and pricing models are built with compliance and risk minimization in mind
  • Design scalable systems across contracting, compliance, governance, privacy, employment, and IP
  • Manage outside counsel across corporate, regulatory, employment, and litigation matters
  • Support fundraising, board matters, corporate governance, and investor communications
  • Proactively identify legal risk areas and implement preventive frameworks

About You

  • 8–10+ years of legal experience across law firm and in-house environments
  • Broad, "full-stack" experience across commercial, corporate, compliance, IP, employment, and litigation oversight
  • Builder mentality — energized by creating structure from scratch
  • Strong executive presence and business judgment
  • Comfortable operating in fast-moving, ambiguous environments
  • Able to partner closely with product and engineering teams
  • Motivated to scale and eventually build a Legal team

Compensation

$250,000 – $325,000

Owner is open to increased compensation at the General Counsel level and may stretch beyond the posted range for the right candidate.

Perks

Comprehensive health coverage, Bay Area-based remote flexibility, unlimited PTO, and additional growth-stage benefits.

Interested?

This search is being led by Wolf at Whistler Partners. Please contact them for a confidential conversation.

About Whistler Partners

Matchmakers, Not Headhunters

Whistler Partners is a boutique matchmaking firm focused on counseling the best and the brightest attorneys over the course of their careers. We believe that the right move comes from working closely with talent to curate their long-term career paths. When it comes to career advice, what matters is not the size of the agency but the strength of your individual recruiter.

We readily admit that we are elite and only work with the best – after all, a little elitism is okay when it comes to your career. Employers love us because we are picky about whom we represent, and attorneys love us because we get them their dream jobs.

Not Specified
Sr. Director Quality Assurance & Regulatory Affairs
🏢 Moximed
Salary not disclosed
Fremont, CA 1 week ago

THE OPPORTUNITY


The Senior Director of Quality Assurance and Regulatory Affairs is a critical member of the leadership team, responsible for establishing and leading the company’s quality and regulatory function, as well as the champion for Moximed’s total quality management system for orthopedic implants and single-use instruments.


This leader oversees all aspects of quality assurance, quality control, regulatory affairs, compliance, and post-market surveillance. They will also guide the regulatory strategy needed to support current commercial products and future pipeline innovations in conjunction with senior management.


The Senior Director will define organizational structure, hire key roles, and foster talent development within the QA and RA department to help ensure successful completion of projects and company milestones in close collaboration with Research and Development, Operations, Sales, Marketing and Clinical Affairs.


This role includes being the Regulatory Affairs team representative for interactions with regulatory bodies, primarily the US FDA and as such will oversee activities related to submissions, registrations and listings, and Medical Device Reporting in cooperation with multiple departments.


WHAT YOU'LL DO


Quality Assurance:


  • Provide leadership to the existing Quality Assurance team including managers and individual contributors.
  • Assume primary responsibility for implementation and maintenance of all aspects of the company-wide quality management system. Determine and enforce (through functional groups) quality requirements in accordance with FDA QMSR and ISO standards.
  • Lead preparation and planning for quality programs to support commercial activities and ongoing compliance, including complaint tracking, investigation, trending and reporting program.
  • Direct quality program development with multiple functions (Operations, R&D, Sales & Marketing, external vendors) to assure adequate resources are available to meet project timelines.
  • Organize and promote company-wide quality improvement efforts, including setting annual quality objectives.
  • Hire, train, and manage QA Staff.
  • Advise and consult with internal staff and scientific consultants who contribute to regulatory submissions, ensuring that appropriate information complies with regulatory regulations/standards/guidelines.
  • Direct implementation and ongoing management of international complaint handling system; in compliance with FDA MDR and device vigilance reporting regulations.
  • Act as or designate QA representative on product development teams (design control and risk management); critically review all documentation for submissions for consistency, accuracy and quality.
  • Supervise and provide guidance on day-to-day quality activities including supplier quality/incoming inspection, management review, training, document control, non-conforming material, and corrective and preventive action.
  • Supervise and manage internal audits and inspections including FDA, Cal FDB and others.
  • Review Change Orders, Design Change Notices, etc., for compliance with FDA, and international regulations and standards.
  • Monitor proposed changes in regulations, standards and guidance publications for impact on current and future development strategies.


Regulatory Affairs:


  • Lead and develop a Regulatory Affairs team consisting of external and internal resources.
  • Oversee the company’s regulatory filings including IDEs, supplements and amendments, Post marketing studies and reports, marketing submissions including De Novo and 510(k) and ongoing updates and annual/periodic reports for all company submissions.
  • Organize and lead projects and subprojects related to RA strategies. May enlist external experts and other resources and manage related actions.
  • Responsible for developing and maintaining regulatory affairs operating procedures and work instructions.
  • Lead and/or oversee regulatory activities by reviewing study-related documents in accordance with applicable regulations.
  • Work with external and internal resources for input and ideas for regulatory strategy to address FDA questions and planning for data framing to highlight Moximed technology advantages and context for risk.
  • Act as or designate ‘Responsible Party’ for purposes of submitting information about Moximed’s applicable clinical trials (ACT) on in coordination with the Clinical Affairs department.
  • Ensure the uniform and timely processing of Moximed Medical Device Reports (MDRs) in accordance with FDA regulations and internal operating procedures.
  • Support product development/improvement projects with R&D and Engineering to assure applicable regulatory requirements are met.
  • Provide regulatory strategy guidance to clinical and operations departments.
  • Lead ad/promo review of product labeling, literature and company websites for accuracy, consistency and domestic and international regulatory compliance.
  • Lead activities for State and Federal regulatory licenses, registrations and listings.
  • Responsible for obtaining and maintaining FDA Small Business Designation.
  • Support review of internal operating procedures and other controlled documents to ensure regulatory and quality compliance and consistency with regulatory commitments.
  • Research, prepare and communicate new and changing product regulatory assessments and justifications.
  • Assist with the training and development of personnel on Regulatory requirements.
  • Support the Complaint Handling Unit, particularly with timely regulatory assessments of complaints for reportability determination for any adverse event or malfunction.


ABOUT YOU


  • Bachelor’s or advanced degree preferred in Life Sciences, engineering or other technical discipline or other equivalent job experience.
  • 15+ years of progressive experience in medical device quality assurance and/or regulatory affairs roles. Prior orthopedic medical device experience or experience with Class II/III implantable devices is a plus.
  • Minimum of 12 years of progressive managerial experience successfully managing technical personnel and complex activities as required.
  • Demonstrated strong leadership presence with ability to collaborate cross-functionally and build high-performing teams.
  • Excellent working knowledge of FDA and international regulatory requirements and standards required. Experience with preparing international submissions/registrations required.
  • Organize and lead teams and sub-teams to address complex quality and regulatory strategies in a growth-stage environment.
  • Demonstrates strong organizational skills and the ability to collect and assess data, establish facts and report on findings.
  • Demonstrates the highest levels of integrity, and good interpersonal and presentation skills.
  • Have a working knowledge of ISO13485, 21 CFR820, preferred knowledge of MDR.
  • Possess leadership qualities and be a great team player; possess the ability to communicate clearly and effectively, both orally and in writing; demonstrate capacity to calmly, clearly and consistently communicate regulations to technical functions within the company; possess the ability to handle multiple tasks, and the ability to think strategically while attending appropriately to details.
  • Must be able to read, analyze, interpret and assist in the creation and refinement of company procedures; demonstrate the ability to define problems, collect data, establish facts, draw valid conclusions and report on findings. The candidate must be able to demonstrate the highest level of integrity, excellent negotiation skills, and excellent interpersonal and presentation skills.
  • Strong work ethic.


At Moximed we believe that the unique contributions of all our team members create our success. To ensure that our culture continues to incorporate everyone’s perspectives and experience, we never discriminate based on race, religion, national origin, gender identity or expression, sexual orientation, age, marital, veteran, or disability status


Pay Transparency:

Moximed offers a comprehensive benefits package including competitive pay, health insurance, Disability Insurance, 401K, paid time off plus holidays, and a flexible approach to work schedules. Actual pay will be adjusted based on an individual's skills, experience, education, and other job-related factors such as location as permitted by law. Total compensation may also include additional forms of incentives.

California Pay Range: $160K-$220K

Not Specified
Manufacturing Engineer
Salary not disclosed
Hayward, CA 1 week ago

Manufacturing Engineer


Bay Area, CA (On-site: Richmond, CA)

Full-Time

Confidential | Drug Testing Industry (Stealth Mode)


Peoplework LLC is looking for a highly motivated Manufacturing Engineer to join our client’s team! The primary role will be to lead the daily operations and logistics to manufacture and distribute products for customers. This includes manufacturing production, movement of materials, and oversight of inbound and outbound inventory. The Manufacturing Engineer will partner with Quality and Engineering teams to manage multisite internal manufacturing lines, including line bring up, as well as line transfer to external contract manufacturers as production demands increase. This role is ideal for someone who has a technical background, can establish, and communicate a vision and enjoys being “hands on”. This position reports to the SVP of Operations.



What You’ll Be Responsible For

·       Own setup and qualification of internal manufacturing launch line.

·       Lead internal manufacturing including daily build schedules and operator oversight to achieve production output targets.

·       Manage daily and long-term customer order fulfillment, multi-site production planning, and inventory oversight.

·       Define production cycle times, output requirements, and to ensure timely and cost-effective delivery of all inbound raw materials utilized in the manufacturing process and all customer products.

·       Leverages lean skillset to manage manufacturing efficiency and quality through increased resource productivity, decreased process cycle times, and scrap reduction.

·       Responsible for product quality and exceeding customer quality and delivery expectations.

·       Assist troubleshooting activities related to product assembly, testing and service issues, including root cause analysis, to achieve a timely resolution.

·       Collaborate with key stakeholders to ensure on time and in budget delivery of production milestones and quality support activities and investigations.

·       Writes and reviews relevant manufacturing documentation such as Product specifications (SPCs), Manufacturing instructions (MPIs), Device History Records (DHRs), and other GMP documents.

·       Deliver status reports, metrics and updates that provide visibility on production goals and outputs.

·       Leads the team in staff training, maintenance and upkeep of manufacturing procedures and policies.

·       Assist in hiring process and creation of relevant job descriptions.

·       Provides guidance in make/buy decisions based on quality, schedule, and cost.




Experience

·       Bachelor’s degree in engineering field, or a related discipline.

·       Alternative: Associate degree, trade school, military technical training, or equivalent experience

·       3+ years relevant experience in manufacturing operations, including direct experience a regulated environment: Medical Device, Pharmaceutical, etc.

·       Experience with manufacturing line start up and process qualifications.

·       1+ years of supervisory experience leading diverse teams in manufacturing operations.

·       Demonstrated excellence achieving process improvements and associated operating efficiencies.

·       Knowledge of GMP manufacturing principles and documentation best practices.

·       Experience working within a structured quality management system.



Work Habits

·       Provides open environment and promotes collaborative teamwork.

·       Works independently and as part of an interdisciplinary team to achieve project goals and timelines as required.

·       Strong verbal, written communication skills.

·       Communicates efficiently with multiple people both internally and externally and prepare and present information to groups.

·       Skillset to lead and motivate others in both matrixed and direct-line management environments.



Why This Role

  • Join a confidential, early-stage drug testing company with meaningful impact on assay development and lab operations
  • Opportunity to work closely with scientists, engineers, and quality teams
  • Competitive compensation and benefits: Salary range: $135,000-$145,000/year.

Due to the stealth nature of the organization, additional details will be shared during the interview process.

Interested?

Apply directly or message me to learn more.




Not Specified
Technical Account Manager
Salary not disclosed
Fremont, CA 1 week ago

Title: Technical Account Manager

Location: Milpitas, Ca

OVERVIEW: LITEON designs and manufactures power supplies, keyboards, ODDs, racks, enclosures, and liquid cooling for a variety of customers in the server, storage, networking, and consumer spaces. With headquarters in Taipei, Taiwan, and branch offices in the United States, LITEON is looking for a creative, best-in-class professional who will thrive in a fast-paced, highly technical environment. The successful candidate will have exceptional communication, leadership, and teamwork skills and will be unafraid of stretching their talents in a dynamic organization where respect and knowledge are far more important than reporting structure. Collaboration with colleagues at all levels will be key to this person’s success at LITEON.


ABOUT THE ROLE:

The Technical Account Manager (TAM) is hands-on and responsible for driving LITEON relationships at the specified strategic account. The primary focus will be on power supplies, liquid cooling, and mechanical enclosures/racks. This person owns the relationship with engineering at the strategic account on behalf of LITEON.


JOB DUTIES AND RESPONSIBILITIES:

  • Drive sales growth and consistently exceed revenue budgets.
  • Conduct quarterly business reviews with Account management, reviewing direction and road mapping.
  • Track monthly reporting attainment to KPI’s once established.
  • Identify and develop opportunities for all LITEON business units.
  • Analyze customer needs and collaborate with management to develop effective strategies.
  • Build strong customer relationships and a comprehensive understanding to influence hierarchy, product, and business roadmaps, vendor selection processes, decision-making criteria, and competitive awareness.
  • Foster a customer-centric mindset, focusing on long-term partnerships.


QUALIFICATIONS:

  • Bachelor’s Degree in Business Administration (or equivalent experience).
  • At least 5 years of related or equivalent experience in the AI Server industry in a Sales Account Manager role.
  • Strong time-management and organization skills for coordinating multiple initiatives, priorities, and implementations of new technology and products into very complex projects.
  • Ability to identify issues, obtain relevant information, analyze and compare data from different sources, and identify alternative solutions.
  • Interprets and seeks information, uses independent reasoning to diagnose the root cause of situations or issues, identifies and tests solutions, and thinks beyond what is typical or customary.
  • Strong written and oral communication skills in English with the ability to effectively collaborate with management and engineering.
  • Ability to manage resources, monitor activities, and assess risks and quality issues associated with the program/project.
  • Language Skill: Bilingual in English/Mandarin is a plus, aligned with business needs.
  • Flexibility to work some evening hours as needed.
  • Proficient in Microsoft Office, including Word, Excel, Outlook, Teams, PowerPoint, and/or other applications to streamline communication and complete tasks.


Benefits

As a full-time employee, you'll have access to LITEON’s comprehensive benefits package, which includes medical, dental, vision, 401(k), and paid time off in compliance with US labor requirements.


Additional Details

LITEON is committed to equal opportunities for all qualified individuals, and we welcome a diverse range of applicants.

Please note that the responsibilities and duties of the position may change with or without notice, and we are committed to providing reasonable accommodation for individuals with disabilities to perform their essential functions.

Not Specified
Physician / Psychiatry / Tennessee / Permanent / Psychiatry Opening in Nashville, TN - Flexible Schedule Job
✦ New
Salary not disclosed

We are seeking to add dedicated Psychiatrists to our team. Salary based with incentive structure and no cap. You will have the opportunity to maximize your potential. Unlike other rigid environments, here you can set your own schedule, work within your own areas of interest and also have the opportunity for greater earnings.

We receive new patient referrals every day so the growing demand for timely care and appointments means that even in today's economy we are a growing company.

We provide care in a multitude of settings including: treatment at hospitals, residential treatment facilities, schools, nursing homes, adult congregate living facilities, partial hospitalization programs. We have an array of outpatient services we offer at 8 offices in South Florida, Colorado, and South Carolina. We offer careers that enable you to meet both your practice and lifestyle goals. This is a physician led practice with innovative approaches to maximizing your time for actual patient treatment. Therefore, you personally are not being inundated with the administrative responsibilities associated with today's health care system. You will receive full administrative, billing, insurance verification, and on-call support, plus usage of company-owned Ritz Carlton time-share, and 70' yacht.

We offer:

  • Flexible scheduling that works with your lifestyle
  • Excellent salary with potential for productivity bonus
  • Company-sponsored health, life, and disability
  • Paid malpractice insurance

Remote working/work at home options are available for this role.
permanent
Physician / Psychiatry / Colorado / Permanent / Psychiatry Opening Colorado Springs, CO - Flexible Schedule Job
✦ New
🏢 Britt Medical Search
Salary not disclosed

We are seeking to add dedicated Psychiatrists to our team. We have several opportunities available, full or part-time, inpatient or outpatient, or a blend of both practice settings. We have a myriad of opportunities and based upon your skills and desires; we design a position that is the closest match for you. This can include inpatient, outpatient, research, and a variety of other modes of treatment. Salary based with incentive structure and no cap. You will have the opportunity to maximize your potential. Unlike other rigid environments, here you can set your own schedule, work within your own areas of interest and also have the opportunity for greater earnings.

We receive new patient referrals every day so the growing demand for timely care and appointments means that even in today's economy we are a growing company.

We provide care in a multitude of settings including: treatment at hospitals, residential treatment facilities, schools, nursing homes, adult congregate living facilities, partial hospitalization programs. We have an array of outpatient services we offer at 8 offices in South Florida, Colorado, and South Carolina. We offer careers that enable you to meet both your practice and lifestyle goals. This is a physician led practice with innovative approaches to maximizing your time for actual patient treatment. Therefore, you personally are not being inundated with the administrative responsibilities associated with today's health care system. You will receive full administrative, billing, insurance verification, and on-call support, plus usage of company-owned Ritz Carlton time-share, and 70' yacht.

We offer:

  • Flexible scheduling that works with your lifestyle
  • Excellent salary with potential for productivity bonus
  • Company-sponsored health, life, and disability

Remote working/work at home options are available for this role.
permanent
Physician / Psychiatry / South Carolina / Permanent / Psychiatry Opening in Charleston, SC - Flexible Schedule Job
✦ New
🏢 Britt Medical Search
Salary not disclosed

We are seeking to add dedicated Psychiatrists to our team. We have several opportunities available, full or part-time, inpatient or outpatient, or a blend of both practice settings. We have a myriad of opportunities and based upon your skills and desires; we design a position that is the closest match for you. This can include inpatient, outpatient, research, and a variety of other modes of treatment. Salary based with incentive structure and no cap. You will have the opportunity to maximize your potential. Unlike other rigid environments, here you can set your own schedule, work within your own areas of interest and also have the opportunity for greater earnings.

We receive new patient referrals every day so the growing demand for timely care and appointments means that even in today's economy we are a growing company.

We provide care in a multitude of settings including: treatment at hospitals, residential treatment facilities, schools, nursing homes, adult congregate living facilities, partial hospitalization programs. We have an array of outpatient services we offer at 8 offices in South Florida, Colorado, and South Carolina. We offer careers that enable you to meet both your practice and lifestyle goals. This is a physician led practice with innovative approaches to maximizing your time for actual patient treatment. Therefore, you personally are not being inundated with the administrative responsibilities associated with today's health care system. You will receive full administrative, billing, insurance verification, and on-call support, plus usage of company-owned Ritz Carlton time-share, and 70' yacht.

We offer:

  • Flexible scheduling that works with your lifestyle
  • Excellent salary with potential for productivity bonus
  • Company-sponsored health, life, and disability

Remote working/work at home options are available for this role.
permanent
QA Automation Engineer II - Jersey City, NJ(Hybrid)
✦ New
Salary not disclosed

Job Title: QA Automation Engineer II

Location: Jersey City, NJ(Hybrid)

Duration: 9+ Months (Extendable)

(\"US citizens and Green Card Holders and those authorized to work in the US are encouraged to apply. We are unable to sponsor H1b candidates at this time.")

A reasonable, good faith estimate of the minimum and maximum hourly rate on W2 for this position is $55 to $67 with limited benefits.

Job Description:

  • 7+ years of proven experience in software quality assurance with a strong focus on test automation.
  • 2+ years of experience in testing and validating ETL processes and data workflows, including data integrity, transformation validation, and end-to-end data pipeline testing.
  • Strong experience with automation frameworks using Selenium WebDriver with Java or C#.
  • Hands-on experience in API and web services testing using automation tools such as Apache JMeter and Rest Assured.
  • Experience designing, developing, and maintaining automated test suites for UI, API, and integration testing.
  • Experience executing and managing automated test scripts within CI/CD pipelines using tools such as Jenkins and Bamboo.
  • Ability to integrate automated test execution into continuous integration and continuous delivery workflows to support automated validation during builds and deployments.
  • Experience analyzing test results, troubleshooting failures, and improving reliability of automated test frameworks.
  • Good understanding of test orchestration, and automated test reporting in CI/CD environments.
  • Good to have: Experience testing applications deployed in cloud environments such as Amazon Web Services.
  • Strong collaboration skills with development, DevOps, and QA teams to ensure high-quality software delivery.

Remote working/work at home options are available for this role.
Not Specified
Engineer, Quality Complaint Investigation (CAPA) - Hybrid
Salary not disclosed
Atlanta, Hybrid 1 week ago
DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm.

Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations.

Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.

Visit us at to learn more and view our open positions.

Please apply or call one of us to learn more For further inquiries about this opportunity, please contact one of our Talent Specialists, Hema, at (63 or Sri Balan at (63 Title
- Engineer, Quality Complaint Investigation (CAPA)
- Hybrid Duration: 9 Months Location: Hybrid at Skaneateles, NY Local candidates preferred Will consider relocation candidates Only W2 candidates are eligible for this position.

Third-party or C2C candidates will not be considered.

Description: I.

SUMMARY: This description outlines the employment prerequisites and job responsibilities for the position of Engineer, Quality Complaint Investigation.

II.

ESSENTIAL FUNCTIONS: This position has primary responsibility for investigation, review, and completion of all Quality Engineering complaint issue analysis tasks utilizing various quality system inputs.

Review individual complaints and associated service data to determine risk level and complete investigation into the as determined problem code and cause codes for each complaint.

Analyze data from various quality inputs (including but not limited to: Field Corrective Action (FCA), Complaints, FDA Medical Device Reports (MDR), etc.) to determine trends and systemic issues.

Prepare and issue reports based on information analysis.

Review existing investigation reports and identify gaps for GMP compliance.

Develop strategies and plans to close the gaps in an efficient and technical manner.

Develop and communicate expectations for quality performance, continuous improvement, and process controls for marketed products.

Monitor and drive corrective action and continuous improvement activities that directly impact performance measures by performing primary investigations, conducting data analysis, and implementing corrective actions.

Conduct or lead corrective and preventive actions in manufacturing using formal problem-solving tools and documentation.

Support CAPA and maintenance activities for existing product lines.

Recommend and/or support projects for improvements to the quality system as approved by management.

III.

QUALIFICATIONS, KNOWLEDGE, AND SKILLS REQUIRED Medical Device Experience with knowledge of 21CFR820 preferred.

Investigational research skills Experience with any statistical software packages (Minitab a plus) Desired experience in the medical device industry in the development and deployment of Quality Systems, process controls, and continuous improvement methods.

Knowledge and working application of FDA cGMP; ANSI/ISO/ASQC requirements; CMDAS (optional).

Knowledge and working application of reading and understanding blueprints and technical drawings.

Demonstrated strong analytical problem-solving (Root Cause Investigations.

Display a solid technical understanding of engineering principles and procedures (e.g., CAD and its application or scheduling a series of technical tasks utilizing software-based tools).

Computer competency in Word, Excel, PowerPoint, Minitab, Access, and databases.

Ability to multitask and methodically manage projects.

IV.

EDUCATION/EXPERIENCE REQUIRED A Bachelor of Science degree in Engineering 1-3 years of Medical Device experience V.

PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee: Must be able to sit for long periods of time Must have good hand-to-eye coordination and dexterity Physical Requirements: Dynamic Lifting capability: Must have the ability to lift 40 pounds at a time.

VI.

WORK ENVIRONMENT Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

This is a manufacturing environment regulated by the FDA and many other work rules to prevent damage to the product we manufacture.

Some of those work rules include, but are not limited to: Wearing a static protective smock at all times while in the work area Wearing a ground wrist strap and plugging that wrist strap into the working table.

Working in proximity to other employees.

Working in an environment that is temperature and humidity-controlled.

Responsibilities: Will be addressing customer complaints and leading complaints investigation.

Identify RCA.

Collaborates with the Engineer, Product service teams and follow-up on service updates.

Quality experience is preferred 2 years would be ideal.

Good to have experience in technical writing and handling class ii medical device.

Will be writing customer feedback letter addressing customer issues and root-cause findings.

Will support the functions of NCQ, CAPA, Audit.

Current team has 2 perm, 3 contract, backfill will be for the 3rd.

Getting about 1000 complaints a month, want to keep it less than 100 actions a week.

Looking for a good communicator who is good at follow-ups.

Proficiency with SAP, ETQ, Trackwise will be preferred.

Will be onsite for Team meeting, addressing complaints, once a month data trending, warehouse visits when required.

Education: Bachelors is a must have.

Interview: Remote/ virtual screening with final onsite interview.

About us: DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond.

The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer.

DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.

SAP, Medical Device, Quality Systems, EtQ
Remote working/work at home options are available for this role.
Not Specified
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