Jobs in Passaic New Jersey
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Granite delivers advanced communications and technology solutions to businesses and government agencies throughout the United States and Canada. We provide exceptional customized service with an emphasis on reliability and outstanding customer support and our customers include over 85 of the Fortune 100. Granite has over $1.85 Billion in revenue with more than 2,100 employees and is headquartered in Quincy, MA. Our mission is to be the leading telecommunications company wherever we offer services as well as provide an environment where the value of each individual is recognized and where each person has the opportunity to further their growth and achieve success.
Granite has been recognized by the Boston Business Journal as one of the "Healthiest Companies" in Massachusetts for the past 15 consecutive years.
Our offices have onsite fully equipped state of the art gyms for employees at zero cost.
Granite's philanthropy is unparalleled with over $300 million in donations to organizations such as Dana Farber Cancer Institute, The ALS Foundation and the Alzheimer's Association to name a few.
We have been consistently rated a "Fastest Growing Company" by Inc. Magazine.
Granite was named to Forbes List of America's Best Employers 2022, 2023 and 2024.
Granite was recently named One of Forbes Best Employers for Diversity.
Our company's insurance package includes health, dental, vision, life, disability coverage, 401K retirement with company match, childcare benefits, tuition assistance, and more.
If you are a highly motivated individual who wants to grow your career with a fast paced and progressive company, Granite has countless opportunities for you.
EOE/M/F/Vets/Disabled
Summary of Position:
Granite Telecommunications is a dynamic and innovative communications services provider for businesses with multiple locations. We specialize in providing one-stop solutions for voice, data, Internet, wireless, video, and secure network options throughout the United States and Canada. As a Business Development Sales Associate, you will play a pivotal role in driving our business expansion through prospecting, cold calling, establishing new relationships, and closing deals that align with our solutions.
Job Responsibilities:
- Prospecting and Lead Generation:
- Conduct thorough market research to identify potential clients and verticals that can benefit from our telecommunications technology solutions.
- Utilize various channels, including social media, industry events, and networking, to identify and generate new leads.
- Collaborate with the marketing team to leverage inbound leads and nurture them through the sales funnel.
- Cold Calling and Outreach:
- Initiate outbound calls and emails to key decision-makers in target organizations.
- Craft compelling and tailored value propositions to pique interest and engage prospects in meaningful conversations.
- Effectively communicate the benefits and unique selling points of our telecommunications technology solutions.
- Establishing New Business Relationships:
- Build and maintain strong, long-lasting relationships with potential clients.
- Understand clients' pain points, challenges, and goals, and position our solutions as the ideal answer to their needs.
- Develop a deep understanding of the telecommunications technology landscape and the competitive advantages we offer.
- Closing Deals:
- Lead negotiations and presentations with prospective clients, addressing objections and concerns.
- Develop and present customized proposals and solutions that align with the client's specific requirements.
- Work collaboratively with internal technical teams to ensure that proposed solutions meet client expectations and technical feasibility.
- Sales Quota Achievement:
- Meet or exceed monthly and quarterly sales quotas to contribute to the overall revenue growth of the company.
- Continuously track and report progress against targets, providing regular updates to the sales management team.
- Utilizing Salesforce:
- Maintain accurate and up-to-date records of all sales activities, interactions, and deals in Salesforce CRM.
- Use Salesforce to manage leads, opportunities, and customer information to facilitate efficient communication and collaboration.
Qualifications:
- Bachelor's degree in Business, Marketing, or a related field (or equivalent work experience).
- Proven track record in sales, with a minimum of 1 year of experience in sales.
- Strong prospecting, cold calling, and lead generation skills.
- Excellent communication and interpersonal skills to build relationships and engage with clients effectively.
- Ability to understand complex technology solutions and translate them into business value for clients.
- Proficiency in using Salesforce CRM or similar sales management tools.
- Results-driven, self-motivated, and capable of working independently or as part of a team.
- Strong organizational skills with the ability to manage multiple leads and opportunities simultaneously.
Benefits:
- Competitive base salary with uncapped commission structure and quarterly bonus.
- Comprehensive benefits package, including health, dental, and retirement plans.
- Ongoing professional development and training opportunities.
- Annual President's Club Trip
- Collaborative and innovative work environment.
- Opportunity for career advancement within a rapidly growing company.
If you're a highly motivated individual who wants to grow your sales career and have uncapped earnings potential with a fast paced and progressive company, Granite has many opportunities for you.
#LI-GC1
#LI-GC1
With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Job Overview
Primary focus is to build product by following processes to meet production goals.
Job Responsibilities and Essential Duties
- Understands and adheres to safety policies and practices.
- Responsible for quality and adheres to manufacturing process requirements and the Getinge Corporation Quality Policy.
- Builds product by following all processes in which trained (in their most current revision), and completing other assigned work, while meeting manufacturing goals and metrics.
- Demonstrates a basic understanding of Lean Manufacturing and related principles
- Maintains accurate records, including training files and shop floor paperwork (SFP).
- Willing to participate in Shared Leadership tasks and responsibilities as directed.
- Understands and follows all Getinge and site-specific policies and procedures.
- Responsible for attending and passing all required Getinge and site-specific training (i.e., QS Basics, Lean Training).
- Demonstrate an understanding of the basic functions of SAP, if applicable.
- Responsible for maintaining individual training records.
- This is not an inclusive list of job responsibilities.
Minimum Requirements
- High School diploma (equivalent) or 3 years of work experience preferred.
- Minimum experience is 0-12 months in a medical device-manufacturing environment.
Required Knowledge, Skills and Abilities
- Demonstrated ability to follow processes and has a moderate understanding of the technical job duties.
- Able to use and understand Basic English communication both written and spoken; demonstrate basic reading, writing and math skills.
- Must demonstrate ability to work effectively in a team setting, be flexible, and exhibit a willingness to learn/ take on new tasks.
The compensation range for this position is between $18.50-$19.00 per hour depending on experience and location
#LI-MV1
About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Benefits at Getinge:
At Getinge, we offer a comprehensive benefits package, which includes:
- Health, Dental, and Vision insurance benefits
- 401k plan with company match
- Paid Time Off
- Wellness initiative & Health Assistance Resources
- Life Insurance
- Short and Long Term Disability Benefits
- Health and Dependent Care Flexible Spending Accounts
- Commuter Benefits
- Parental and Caregiver Leave
- Tuition Reimbursement
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Job Overview
Responsible for assembling products and recording required information to meet production requirements and quality standards. Contribute to the operation of the production area, and ensure compliance with GMP, GDP, ISO, ESD, and all other regulatory requirements.
Job Responsibilities and Essential Duties
- Understand and adhere to safety policies and practices
- Understands and follows all Getinge and site-specific policies and procedures.
- Builds product by following all processes in which trained (in their most current revision), and completing other assigned work, while meeting manufacturing goals and metrics.
- Demonstrated ability to follow and implement GMP, GDP, ESD and all other applicable regulatory requirements
- Full understanding of document control procedures
- Ability to use basic test and measurement equipment
- Demonstrate an understanding of the basic functions of SAP, if applicable
- Determine if components and/or assemblies meet specification and reject if necessary.
- Escalate issues to manager as necessary.
- Maintain accurate records, including shop floor paperwork (SFP)
- Ability to work independently, or as part of a group, and display a high quality of skill in both mechanical
and electronic assembly with a minimum of supervision.
Minimum Requirements
* High School diploma or equivalent, or 3+ years of work experience required.
* Medical device or other regulated manufacturing environment experience preferred but not required
* Must have basic computer skills, SAP experience a plus
* Must be able to work in a team environment
Required Knowledge, Skills, and Abilities
* Knowledge of and ability to use basic small hand tools and power tools
* Knowledge of and ability to use basic test and measurement equipment
* Must have good oral and written communication skills
About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Benefits at Getinge:
At Getinge, we offer a comprehensive benefits package, which includes:
- Health, Dental, and Vision insurance benefits
- 401k plan with company match
- Paid Time Off
- Wellness initiative & Health Assistance Resources
- Life Insurance
- Short and Long Term Disability Benefits
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Job Overview
The Sr. R&D Engineer - CAPA Specialist is a senior individual contributor responsible for leading complex, design and/or R&D controlled QMS process related Corrective and Preventive Action (CAPA) investigations within the Research & Development organization. This role drives robust root cause analysis, corrective and preventive action development, and effectiveness verification to ensure product quality, regulatory compliance, and continuous improvement in design and development processes.
Operating with a high degree of autonomy, this position serves as a technical authority and trusted advisor to R&D teams, providing guidance on structured problem-solving, CAPA best practices, and regulatory expectations. While the role does not include people management responsibilities, it plays a critical mentoring and coaching role within the R&D CAPA ecosystem.
Job Responsibilities and Essential Duties
- Lead and execute product design and or Design Controls process related CAPA investigations within the R&D organization, from problem definition through implementation and effectiveness verification.
- Perform thorough and structured root cause analyses for design, verification, validation, and product performance issues using appropriate analytical tools and data.
- Develop and drive robust corrective and preventive actions that are risk-based, technically sound, and aligned with design controls and risk management processes.
- Ensure CAPA documentation is accurate, complete, and compliant with FDA regulations, ISO 13485, and internal quality system requirements.
- Collaborate closely with cross-functional partners-including Quality, Regulatory Affairs, Operations, and Manufacturing Engineering-to address systemic and cross-functional issues.
- Provide technical guidance, coaching, and informal mentorship to R&D engineers and associates on CAPA processes, problem-solving methodologies, and regulatory expectations.
- Support CAPA owners in developing realistic timelines, following CAPA SOPs, and defining appropriate effectiveness verification plans and acceptance criteria.
- Support internal and external audits and inspections by providing CAPA documentation, investigation rationale, and technical explanations.
- Maintain clear traceability between CAPA investigations, corrective actions, effectiveness checks, and related design and risk documentation.
- Identify opportunities to improve CAPA execution quality and efficiency and contribute to broader quality system and R&D process improvements.
- Serve as a technical CAPA subject matter expert within the R&D organization.
Minimum Requirements
- Bachelor's degree in Engineering or related technical discipline; advanced degree preferred.
- 5+ years of experience in R&D engineering within a medical device organization.
- Demonstrated experience managing and executing CAPA activities within product design and development.
- Strong understanding of regulatory requirements, including FDA regulations and ISO 13485.
Required Knowledge, Skills and Abilities
- Expert-level knowledge of CAPA methodologies and root cause analysis tools (e.g., Fishbone, 5 Whys, FMEA) and risk management practices.
- Strong analytical and problemsolving skills with exceptional attention to detail.
- Ability to provide clear technical guidance and support to junior engineers without direct supervisory responsibility.
- Effective verbal and written communication skills for presenting findings across all organizational levels.
- Experience creating statistically sound sampling plans and acceptance criteria for effectiveness verification.
- Proficiency with CAPA and documentation systems; TrackWise experience preferred.
- Indepth knowledge of medical device regulations, design control processes, and quality system expectations.
Salary Range: $115k - $140k
About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Benefits at Getinge:
At Getinge, we offer a comprehensive benefits package, which includes:
- Health, Dental, and Vision insurance benefits
- 401k plan with company match
- Paid Time Off
- Wellness initiative & Health Assistance Resources
- Life Insurance
- Short and Long Term Disability Benefits
- Health and Dependent Care Flexible Spending Accounts
- Commuter Benefits
- Parental and Caregiver Leave
- Tuition Reimbursement
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
Duration: 2 months
Location: Secaucus NJ 07094
Shift/Time Zone: M - F 8:30 - 5pm, possibly OT
Summary
Perform administrative duties to support Director and/or large staff
About the Role
* This is not a traditional Executive Assistant role.
* This is a high-exposure, high-accountability position for someone who wants to learn how senior leaders operate, how decisions are made, and how large teams scale.
* You will operate as an extension of the executive - managing time, information flow, priorities, and strategic preparation. Over time, the role can evolve toward operations leadership or Chief of Staff-type responsibilities for the right person.
* If you are looking for a reactive, checklist-based administrative job, this is not it.
* If you want accelerated growth, real ownership, and direct exposure to leadership decision-making, read on.
What You'll Own
* Executive calendar architecture and time optimization
* Meeting preparation and follow-up execution
* Decision-support briefs (distilling complexity into clarity)
* Inbox triage and communication drafting
* Strategic project coordination
* Identifying inefficiencies and proposing improvements
* Anticipating issues before they escalate
* Other duties as assigned to meet business needs
What "Great" Looks Like
* You anticipate problems before they surface
* You create order from ambiguity
* You improve systems instead of maintaining broken ones
* You are comfortable pushing back respectfully
* You learn fast and operate with urgency
* You view this role as a launchpad, not a landing spot
Ideal Background (Non-Exhaustive)
* Business operations, consulting, startup, military leadership, or high-performance hospitality
* 2-6 years of high-accountability experience
* Evidence of upward trajectory
* Exceptional written communication
What You'll Gain
* Direct exposure to executive decision-making
* Rapid professional growth
* Clear performance feedback
* Increasing responsibility based on performance
* Compensation is competitive and aligned with performance and growth potential.
Qualifications HS Diploma or Equivalent - Required Bachelor's Degree - Business or related field - Preferred
Location: Newark, NJ (Hybrid)/Fort Washington, PA (Hybrid)
Duration: 12 Months
Job Description:
We are seeking a highly skilled and experienced Business Analyst with a background in implementing effective contact center/IVR solutions. The ideal candidate will have a proven track record in supporting AI-driven transformations in the IVR and chatbot space. This role requires a deep understanding of customer service operations, actionable business intelligence, data modeling, and governance, especially within the financial services industry.
Key Responsibilities:
* Experience in modernizing IVR flows into customer-centric, adaptive, and learning-oriented conversational journeys powered by AI agents.
* Ability to capture and translate business needs into agentic AI-focused requirements, shifting from traditional deterministic IVR call flow logic to flexible, goal oriented conversational behaviors.
* Evaluate business processes, anticipate requirements, and uncover areas for improvement ensuring strategic alignment and operational efficiency.
* Develop actionable business intelligence and analytics to drive decision-making.
* Lead ongoing reviews of business processes and developing optimization strategies.
* Develop and implement data governance, data management, and data quality program practices and strategies.
* Model business processes for Interactive Voice Response (IVR) and implement effective solutions.
* Foster a culture of continuous improvement and excellence.
What you bring to the table:
* Demonstrated experience in redesigning IVR systems (for self-service on the voice channel) and leveraging AI solutions in the IVR space.
* Experience working in an AGILE environment.
* Strong analytical skills and proficiency in data modeling techniques.
* BA/BS in CS, Information Systems or Information management or Systems design.
* Ability to manage complex projects and deliver results in a fast-paced environment.
* Excellent communication and leadership abilities.
Bonus if you have:
* Deep expertise in insurance financial engines and regulatory compliance.
* Knowledge of SQL, Databases and Analytical/Reporting tools such as PowerBI/Tableau.
Location: Remote
Duration: 6 months
Role Overview
The Integration Architect defines, designs, and governs enterprise integration architecture standards across AWS, Azure, Microsoft Fabric, and on-prem systems. This consultant creates scalable integration blueprints, reusable patterns, and secure connectivity frameworks that ensure interoperability, reliability, and domain-aligned data exchange. The role partners closely with domain teams, platform engineering, API management teams, and enterprise architecture to accelerate delivery while maintaining architectural integrity.
Key Responsibilities
Integration Standards & Governance
- Define and maintain enterprise standards for API design, event schemas, messaging patterns, and integration of contracts.
- Establish integration governance across AWS, Azure, MS Fabric, and on-prem systems.
- Define patterns for ADS (Authorized Data Sources) alignment, data contracts, schema evolution, and anchor key management.
- Enforce adherence to enterprise security principles, including OAuth2/OIDC, JWT, TLS, Zero Trust patterns.
Blueprints & Reference Architecture
- Build and maintain unified enterprise integration architecture blueprints spanning cloud, Fabric, and on prem connectivity.
- Create domain specific and cross domain integration flow maps, canonical API patterns, and event driven reference architectures.
- Align AWS, Azure, MS Fabric, and on-prem patterns under Unified Architecture.
Reusable Patterns & Engineering Enablement
- Develop reusable integration patterns for:
- AWS: API Gateway, Event Bridge, SNS/SQS, Lambda, Step Functions, Glue, EMR, Redshift, Lake Formation, Kinesis, AWS Batch, AWS ECR, AWS ECS Fargate.
- Azure: APIM, Functions, Service Bus, Azure Data Factory (all IR types), Azure Synapse Pipelines, Azure Stream Analytics, Azure Batch, Azure Data Explorer ingestion.
- MS Fabric: Data Factory pipelines, Lakehouse ingestion interfaces, Fabric Data Pipelines, Notebook-based ETL, Warehouse ingestion.
- On prem: MFT, MQ, legacy services.
- Provide templates for API contracts, event schemas, integration error handling, observability hooks, and resiliency patterns.
Metadata, ADS, & Anchor Key Integration
- Define integration patterns incorporating ADS rules, domain ownership, and anchor key management for interoperability.
- Ensure all integration patterns embed security, observability, lineage awareness, and operational resiliency.
- Collaborate with data governance to ensure consistent entity resolution and cross?domain identifier mapping.
Domain Engagement & Architecture Review
- Guide domain teams in implementing target state integration architectures.
- Lead or participate in architecture reviews for API designs, event models, platform integrations, and connectivity.
- Recommend modernization opportunities to retire from legacy integration mechanisms and adopt event-driven/API?first models.
Qualifications
Technical Expertise
- 8-12+ years in integration architecture, API engineering, event-driven design, or hybrid integration.
- Strong hands-on expertise across:
- AWS: API Gateway, Event Bridge, SNS/SQS, Lambda, Step Functions, Glue, EMR, Redshift, Lake Formation, Kinesis, AWS Batch, AWS ECR, AWS ECS Fargate.
- Azure: APIM, Functions, Service Bus, Azure Data Factory (all IR types), Azure Synapse Pipelines, Azure Stream Analytics, Azure Batch, Azure Data Explorer ingestion.
- MS Fabric: Data Factory pipelines, Lakehouse ingestion interfaces, Fabric Data Pipelines, Notebook-based ETL, Warehouse ingestion.
- RDBMS: SQL, Oracle, DB2, RDS, etc.
- On prem: MQ, MFT, REST/SOAP services.
- Understanding of ADS, anchor key management, data/domain contracts, lineage aware integration.
- Experience designing event driven, API first, batch, and hybrid integration architectures.
Location: Clifton NJ 07012
Duration: 6 months
Shift/Time Zone:
Sunday to Thursday 9am-5:30pm
JOB SUMMARY:
Perform the daily activities as described below. Basic Purpose: Perform various routine laboratory functions in a precise and accurate fashion to assist the laboratory professional staff and to facilitate production.
JOB REQUIREMENTS:
- Sorting, and receiving specimens in the department.
- Performs routine instrument maintenance on some equipment.
- Performs laboratory tasks of centrifuging specimens, printing extra labels, recording data (temperature charts) specimen storage and retrieval.
- Preparing reagents and or media in the department.
- Preparing specimens at workstations for testing. (Including building worklists, aliquoting specimens into sample cups, checking specimens for clots and fibrin, inoculation, slide preparation)
- Performs QA/QC duties as assigned.
- Resolves pending lists.
- Finds missing samples.
- Decontaminates work areas.
- Performs weekly radioactive wipe tests.
- Maintains files for department records.
- Changes gas cylinders.
- Follows all PPE requirements and all safety regulations.
- Uses the laboratory computer system as well as operates PCs.
- Disposes of biohazardous material.
- Completes training and competency checklists as appropriate.
- This is not an exhaustive list of all duties and responsibilities, but rather a general description of the work performed by this position.
Education:
- High school diploma or equivalent.
- Medical assistant training helpful.
- Math and science courses preferred.
Work Experience: None required
Special Requirements:
- Must have the ability to establish work priorities and to handle several tasks for maximum workstation efficiency.
- Must be able to retain information once learned.
- Must interact with other coworkers, internal and external customers with courtesy and respect.
- Key Word Search: laboratory, medical
With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Job Overview
Responsible for processing incoming materials including kitting/picking for production needs. Knowledge of all related procedures. Position will also include cycle counting, shipping, warehouse, and mailroom responsibilities.
Job Responsibilities and Essential Duties
- Receiving, and incoming materials processing
- Inspect & pack (lot preparation) according to specific procedures.
- Distribute components and supplies to Manufacturing.
- Perform all transactions according to procedures.
- Perform mail services such as pickup/drop off at Post Office, sorting, delivery within building, and maintenance and service of postal machine.
- Pack Items to be shipped.
- Inventory control and cycle counting.
- Handle chemicals and hazardous waste per procedure.
- Handle and deliver customer complaint items.
- This is not an inclusive list of job responsibilities.
Minimum Requirements
- High School Diploma or equivalent is required.
- Minimum 1-year prior experience working in a warehouse or distribution center is preferred.
- Open to working the 2nd shift (2:00PM - 10:30PM). There is some potential flexibility on hours
- Experience working in a regulated environment such as medical device, aerospace, pharmaceutical, etc. is preferred
Required Knowledge, Skills, and Abilities
- SAP or other ERP software knowledge preferred.
- Basic proficiency with Microsoft Office or equivalent software application is preferred.
- Must have a valid drivers' license.
This is a "Defined Term" assignment that will last approximately 24 months or until project is complete. Defined Term employees areeligible for mostbenefits (including health insurance and paid time off) while on assignment.
Hourly Salary range - $19.80 - 23.00
#LI-BS1
About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Benefits at Getinge:
At Getinge, we offer a comprehensive benefits package, which includes:
- Health, Dental, and Vision insurance benefits
- 401k plan with company match
- Paid Time Off
- Wellness initiative & Health Assistance Resources
- Life Insurance
- Short and Long Term Disability Benefits
- Health and Dependent Care Flexible Spending Accounts
- Commuter Benefits
- Parental and Caregiver Leave
- Tuition Reimbursement
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Job Overview
The Quality Engineer I Quality Operations specializes in Quality Operations, and is responsible for overseeing and improving the quality of manufacturing processes, ensuring compliance with regulatory requirements, and driving continuous improvement initiatives to enhance product quality and customer satisfaction. You will play a key role in ensuring that our manufacturing operations meet the highest standards of quality and efficiency while adhering to relevant regulations and industry best practices.
Job Responsibilities and Essential Duties
- Develop, implement, and maintain quality control processes and procedures for manufacturing operations to ensure compliance with regulatory requirements and industry standards.
- Establish and monitor key performance indicators (KPIs) to assess manufacturing quality and identify opportunities for improvement.
- Participate/ Lead validation and verification activities for manufacturing processes, equipment, and software systems to ensure they meet quality and regulatory requirements.
- Develop/ review validation protocols, execute validation studies, and analyze data to ensure process robustness and reliability.
- Ensures through Design Transfer activities the Device Master Records (DMRs) contents are developed, controlled, and maintained leading to Risk based Manufacturing Control Plans.
- Support/ Investigate and resolve Out of Tolerance events identified during equipment/ instrument calibrations.
- Investigate product nonconformances, conduct root cause analysis, and implement corrective and preventive actions (CAPA).
- Track and monitor CAPA effectiveness to ensure issues are resolved and prevented.
- Support the Health and Hazard Evaluation process by gathering required data and performing in-depth analysis prior to sharing the information with the Field Action Committee.
- Implement corrective and preventive actions (CAPAs) to address root causes and prevent recurrence of quality issues.
- Facilitate risk management activities related to manufacturing processes, identifying, and mitigating risks to product quality, safety, and efficacy.
- Implement risk-based decision-making processes to prioritize quality activities and allocate resources effectively.
- Lead and support continuous improvement projects aimed at enhancing manufacturing processes, reducing defects, and optimizing productivity.
- Utilize quality tools and methodologies, such as Six Sigma, Lean Manufacturing, and Statistical Process Control (SPC), to drive process optimization and waste reduction.
- Ensure compliance with applicable regulations, including FDA Quality System Regulation (QSR), ISO 13485, and other international standards.
- Support both internal and external audits as an SME for Production & Process Controls and presents records of activities related to Design Transfer for New Product Development and Design Changes.
Minimum Requirements
- Bachelor's degree in engineering, Science, or other related field is required.
- Six Sigma Green Belt or other applicable certifications are a plus.
- Minimum 1 year experience in Quality or Engineering.
- Experience in a medical device or pharmaceutical industry.
- Experience with Class III disposable and/or Electro-Mechanical medical devices is preferred.
- Knowledge and understanding of the US Food and Drug Administration (FDA) 21 CFR 820, ISO 13485, ISO 14971, EU MDD, and EU MDR. Knowledgeable on specific requirements for Design Controls and Risk Management is preferred.
- Knowledge of application & selection of Sampling Plans, to support Risk based Manufacturing Controls Plans.
- Project management and leadership experience is desirable.
- Knowledge of Microsoft Office Products such as Word, Excel, or equivalent software applications.
Required Knowledge, Skills and Abilities
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills.
- Proficiency in quality tools and methodologies (e.g., Six Sigma, FMEA, Gage R&R).
- Ability to work effectively in a cross-functional team environment.
- Ability to review and understand technical standards and their requirements for products.
- Lead improvement initiatives, either independently or as part of cross-functional teams
The base salary for this the position is a minimum salary of $87,000 and a maximum of $90,000 with 8% annual bonus
About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
