Engineering Jobs No Experience Jobs in Warwick
422 positions found
With a North American presence of over 100 years, we operate as the market leader with over 50 offices throughout the US and Canada.
By connecting global resources and local experience, Keller develops innovative, practical, and cost-effective solutions to geotechnical challenges.
Our values of integrity, collaboration, and excellence enable us to lead the industry in providing the optimal solution for our clients.
We are seeking a CAD Technician to join our New England area office who has the desire to work in an industry leading company with a reputation for excellence.
This position involves drafting and plan take-offs, under general supervision, to produce bid take-offs, engineering drawings from sketches, mark-ups, existing as-builts, site maps, photos, field notes and existing AutoCAD drawings.
You will be responsible for creating construction documents, as-builts, sketches, and graphics while working directly with the engineers and project managers of our Midwest branches.
Responsibilities Responsibilities: Draft engineering and construction documents using AutoCAD Review plans and prepare take-offs for estimating purposes Create a basic set of construction drawings and individual sheets Utilize standard engineering practices and techniques to adjust and correlate data Prepare engineering plans, plots and reports Revise drawings from markups and/or instructions Complete assigned tasks on all projects in a timely manner to ensure deadlines are met Qualifications Requirements: Bachelor’s degree is preferred but not required 2 years of Engineering/Architecture Drafting experience Proficiency in AutoCAD and Microsoft Suite software Experience with 3D modeling.
Proficiency in Revit and Sketchup are preferred but not required Perform tasks and solve problems with a high degree of independence Excellent written and verbal communication skills in a dynamic environment Strong organizational, time management, attention to detail and analytical skills Ability to work independently as well as in a team environment #LI-BP1 Additional Information Salary Range: $60,000.00
- $80,000.00 per year DOE Actual salary will be based on a variety of factors including relevant internal and external experience, knowledge, skills, scope of job, geographical location or other factors permitted by law Benefits: 401(k) + matching Health, Dental, Vision insurance Life insurance Paid time off (PTO) Holiday Pay Keller is an Equal Opportunity Employer.
We encourage qualified women, minorities, veterans, individuals with disabilities, and others to apply.
Equal Employment Opportunity
Location:
Barrington, RI
Company:
Western Express
Pay:
$0.40 to $0.48 per mile
Route Type:
otr, regional
Start Date:
ASAP
About the Position
CALL TO SPEAK WITH A SEATING SPECIALIST TODAY!
(833) 615-1594
Why wait to earn more?
Western Express has immediate openings for entry level company truck drivers and driver trainers. With our newly increased pay package, you'll earn one of the highest rates in the industry!
CALL (833) 615-1594
or
APPLY NOW ! Limited opportunities!
We Offer:
GREAT PAY
– Recent grads can make up to
$80,000
their
FIRST YEAR!
HIGH RATES
– Start up to
48 CPM
+ increase up to
53 CPM
within your
first year !
RELIABLE HOME TIME
– Get home every 12-16 days with OTR or
home every week
with Regional!*
Experienced top earners and trainers make up to
$100,000
per year!
Outstanding Team incentives: Up to
$3,400/week
per team!
Choose Flatbed or
100% no-touch
Dry Van freight with 60-80%
drop and hook *
$1,000
driver referral bonuses –
unlimited!
Dependable trucks : Well-maintained fleet equipped with the
latest safety technology
Excellent Benefits: Health, Dental and Vision + 401k
Pet & Rider policies
Paid Vacation
NO EXPERIENCE NECESSARY ! WE WILL GIVE YOU THE TRAINING YOU NEED! (CDL-A required)
INTERESTED IN BEING A DRIVER TRAINER?
Drive with Western for 3 months or more and you can qualify as a driver trainer at Western Express! Call today for more details on how you can earn up to
$100,000 annually !
Have you been out of driving for 3 years or more? Are you a recent CDL-A grad? Call us for information about our Training Programs today!
Western Express is a non-discriminatory and equal opportunity employer. Regardless of your background, we'd like to speak with you to see if you qualify.
*Flatbed/Van freight and regional fleet availability subject to geographical eligibility.
**Subject to change without notice. Additional restrictions may apply. Call for details.
Requirements
Valid CDL-A (Class A CDL)
21+ Years of Age
Location:
Barrington, RI
Company:
Western Express
Pay:
$0.40 to $0.63 per mile
Route Type:
otr
Start Date:
ASAP
About the Position
CALL TO SPEAK WITH A SEATING SPECIALIST TODAY!
(833) 615-1594
Real Miles. Real Money.
Western Express has immediate openings in our Flatbed and Dry Van divisions for company drivers and driver trainers! With our newly increased pay package, you'll earn one of the highest rates in the industry!
CALL (833) 615-1594 or APPLY NOW!
Limited opportunities!
We Offer:
GREAT PAY
– Earn up to
$100,000
per year!
HIGH RATES
– Experienced drivers now earn up to
56 CPM !
NEW SAFETY BONUS -
Qualify for an
extra 5 CPM
(van) or
extra 7 CPM
(flatbed) and take home up to
$800 more
every month!*
Dependable trucks : Well-maintained fleet equipped with the
latest safety technology
Choose Flatbed or
100% no-touch
Dry Van freight with 60-80%
drop and hook **
Outstanding Team incentives: Up to
$3,400/week
per team
$1,000
driver referral bonuses –
unlimited!
Excellent Benefits: Health, Dental and Vision + 401k
Pet & Rider policies
Paid Vacation
NO EXPERIENCE NECESSARY ! WE WILL GIVE YOU THE TRAINING YOU NEED! (CDL-A required)
INTERESTED IN BEING A DRIVER TRAINER?
Drive with Western for 3 months or more and you can qualify as a driver trainer! Call today for more details on how you can earn up to $100,000 annually!
Have you been out of driving for 3 years or more? Are you a recent CDL-A grad? Call us for information about our Training Programs today!
Western Express is a non-discriminatory and equal opportunity employer. Regardless of your background, we'd like to speak with you to see if you qualify.
*Safety bonus eligibility conditions apply, including minimum mileage, accident-free driving and more.
**Flatbed/Van freight and regional fleet availability subject to geographical eligibility.
***Subject to change without notice. Additional restrictions may apply. Call for details.
Requirements
Valid CDL-A (Class A CDL)
21+ Years of Age
Location:
Barrington, RI
Company:
Western Express
Pay:
$0.40 to $0.82 per mile
Route Type:
regional
Start Date:
ASAP
About the Position
CALL TO SPEAK WITH A SEATING SPECIALIST TODAY!
(833) 615-1594
Miss less. Earn More.
Western Express has HIGH PAYING REGIONAL truck driving opportunities now available for Dry Van and Flatbed! You will stay close to home driving familiar lanes with miles you can count on! Regardless of your experience, CALL
(833) 615-1594
or APPLY NOW! Limited opportunities!
We Offer:
GREAT PAY
– Earn up to $1,700 weekly!
HIGH RATES
– Up to
75 CPM minimums
with qualifying mileage/deliveries
NEW SAFETY BONUS - Qualify for an
extra 5 CPM
(van) or
extra 7 CPM
(flatbed) and take home up to
$800 more
every month!*
WEEKLY HOME TIME
– Get
home every week
or stay out for extra money!
Dependable trucks : Well-maintained fleet equipped with the
latest safety technology
Stay moving: 100%
no-touch
freight and 60-80%
drop and hook ! (Dry Van Only)
$1,000
driver referral bonuses – unlimited!
Excellent Benefits: Health, Dental and Vision + 401k
Pet & Rider policies
Paid Vacation
NO EXPERIENCE NECESSARY ! WE WILL GIVE YOU THE TRAINING YOU NEED! (CDL-A required)
INTERESTED IN BEING A DRIVER TRAINER?
Drive with Western for 3 months or more and you can qualify as a driver trainer! Call today for more details on how you can earn up to
$100,000
annually!
Have you been out of driving for 3 years or more? Are you a recent CDL-A grad? Call us for information about our Training Programs today!
Western Express is a non-discriminatory and equal opportunity employer. Regardless of your background, we'd like to speak with you to see if you qualify.
*Safety bonus eligibility conditions apply, including minimum mileage, accident-free driving and more.
**Subject to change without notice. Additional restrictions may apply. Call for details.
Requirements
Valid CDL-A (Class A CDL)
21+ Years of Age
Want to make extra money on YOUR schedule? Join our exclusive list of research study participants and start earning extra income today!
Perfect for anyone seeking remote, part-time, or temporary work, these opportunities require no previous experience and offer unmatched flexibility. Choose the studies that suit you best—whether online, in-person, or over the phone—and get paid for sharing your opinions.
Don't miss out on this chance to turn your free time into valuable earnings!
Participants are needed on a wide range of topics such as:
- Health Issues (Research for cures and new medications to treat ailments)
- Consumer Products (Your experience with consumer products)
- Shopping (Shopping experiences)
- Internet Usage (How you use the internet)
- Vehicles (recreational vehicles and automobiles)
- Employment (Various types of jobs or career fields)
- Food & Beverages (the consumption of various foods and beverages)
- Entertainment (About TV, movies or video games)
- Social Media (the use of different social media platforms)
- Financial (Banking and investing)
- Retirement (Planning what, when and how)
- Gender (studies based on your gender)
- Housing (Renters or Homeowners)
Compensation:
- Earn up to $250+ in Just ONE Hour! (Focus Group Session)
- Earn up to $3,000+ (Multi-Session Studies)
Benefits:
- Flexibility to take part in discussions online or in-person.
- No commute needed if you choose to work from home.
- No minimum hours. You can do this part-time or full-time
- Enjoy free samples from our sponsors and partners in exchange for your honest feedback of their products.
- You get to review and use new products or services before they are launched to the public.
Qualifications:
- Speak and/or read English
- Must be 18yrs old or older
- Must have either a phone, computer or tablet with internet connection
Experience:
- Start Immediately - No Experience Needed! Anyone Can Participate!
Education:
- Open to all education levels - Your opinion matters!
Remote working/work at home options are available for this role.
Want to make extra money on YOUR schedule? Join our exclusive list of research study participants and start earning extra income today!
Perfect for anyone seeking remote, part-time, or temporary work, these opportunities require no previous experience and offer unmatched flexibility. Choose the studies that suit you best—whether online, in-person, or over the phone—and get paid for sharing your opinions.
Don't miss out on this chance to turn your free time into valuable earnings!
Participants are needed on a wide range of topics such as:
- Health Issues (Research for cures and new medications to treat ailments)
- Consumer Products (Your experience with consumer products)
- Shopping (Shopping experiences)
- Internet Usage (How you use the internet)
- Vehicles (recreational vehicles and automobiles)
- Employment (Various types of jobs or career fields)
- Food & Beverages (the consumption of various foods and beverages)
- Entertainment (About TV, movies or video games)
- Social Media (the use of different social media platforms)
- Financial (Banking and investing)
- Retirement (Planning what, when and how)
- Gender (studies based on your gender)
- Housing (Renters or Homeowners)
Compensation:
- Earn up to $250+ in Just ONE Hour! (Focus Group Session)
- Earn up to $3,000+ (Multi-Session Studies)
Benefits:
- Flexibility to take part in discussions online or in-person.
- No commute needed if you choose to work from home.
- No minimum hours. You can do this part-time or full-time
- Enjoy free samples from our sponsors and partners in exchange for your honest feedback of their products.
- You get to review and use new products or services before they are launched to the public.
Qualifications:
- Speak and/or read English
- Must be 18yrs old or older
- Must have either a phone, computer or tablet with internet connection
Experience:
- Start Immediately - No Experience Needed! Anyone Can Participate!
Education:
- Open to all education levels - Your opinion matters!
Remote working/work at home options are available for this role.
Job Description
- New Supplier Aspen development requirements
- High Level issues that found during eSD evaluation need to be resolved and justification.
- Business Operating Systems and Quality Operating Systems do not follow IATF standard.
- Lack of KPI’s in displayed in the facility.
- Lack of Shop floor visual management.
- Needs management structure to identify manufacturing issues and implement Corrective Action Plans.
- People-Training plans.
- Poor problem solving.
- Poor Housekeeping and maintenance planning.
- Introduction of Layered Process Audit system.
- Cleanliness regime introduction.
- Program and Launch management structure unclear.
- In order to mitigate the above STA require a dedicated Engineer for 12 Months duration to resolve Supplier development issues. 2 sites involved
- Rhode Island – raw material manufacture into Aerogel
- Monterey in Mexico – Aerogel cut to size & encapsulated.
Ideal Person
- Experienced in both Supplier Development and New Model Launch Environment.
SD Key Skills
- Extensive knowledge and practical deployment of lean tools and demonstrated experience in process/value stream mapping.
- Change leadership/management skills with the ability to challenge and drive operational excellence.
- Analytical skills to break down complex, multidimensional problems or processes and drive improvement ideas from concept to reality.
- A proven leadership track record in a manufacturing or technical environment
- Broad experience of managing external stakeholders and supplier relationship management.
- Ability to evaluate capacity at a facility and workstation level.
- Practical background in the implementation of best practice factory operating systems (People, Production, Quality, Planning & Logistics)
- Knowledge of IATF16949 and AIAG standards
NML Key Skills
- Core knowledge of NML activity.
- Core knowledge of APQP and PPAP
- Manage supplier process development and introduction to support delivery of quality requirements
- Manage productive relationships with internal stakeholder and supplier’s representatives to ensure all supplier manufacturing process related APQP deliverables are met.
A compromise would be someone with Supplier Development Skill Set only. The main requirement is to work with the supplier to meet Client requirements, however in this case US STA NML resource would be required to support the activity in Aspen which would result in reduced current car activity.
Want to start your journey with the Navy?
Apply Now
Officer None
What to Expect
Information Professional Officer
More Information
Responsibilities
Information Professional Officers (IPOs) oversee the seamless operation of the global Naval network environment. Their responsibilities include:
- Leading the Naval network warfare missions in developing tactics and procedures to realize tactical, strategic and business advantages afloat and ashore
- Driving interoperability with joint, allied and coalition partners
- Building professional excellence through education, training and certification and milestone qualifications
- Optimizing organizational effectiveness through cutting-edge technologies, knowledge management techniques and a culture of innovation
- Helping to develop and deploy information systems, command and control and space systems
- Serving as a key part of the Information Dominance Corps in its mission to gain a deep understanding of the inner workings of adversaries
- Overseeing the work of Information Systems Technicians - Enlisted Sailors (no degree required) who serve as specialists in information technology
Work Environment
Information Professionals serve in challenging roles of increasing scope and responsibility both afloat and ashore. This could include:
- Serving as part of Battle Group staffs on ships at sea
- Working in C4I/Space/Surveillance on shore tours
- Serving on major Navy and joint staffs
- Serving in command of key communication and surveillance facilities around the globe
Training & Advancement
Those pursuing an Information Professional Officer position are required to attend Officer Candidate School (OCS) in Newport, RI.
Upon completion, candidates typically attend a five-week IP Basic Course of instruction in Pensacola, FL, before or during their initial assignment. IPOs must complete specific qualifications as part of their training during Fleet tours and are expected to pursue advanced education opportunities.
Promotion opportunities are regularly available but competitive and based on performance.
Post-Service Opportunities
Specialized training received and work experience gained in the course of service can lead to valuable credentialing and occupational opportunities in related fields in the civilian sector.
Education Opportunities
Wherever you are in your professional career, the Navy can help ease your financial burdens and advance your career with generous financial assistance and continuing education programs. Beyond professional credentials and certifications, Information Professional Officers can advance their education by:
- Pursuing opportunities at institutions such as Naval Postgraduate School (NPS) or Navy War College (NWC)
- Completing Joint Professional Military Education (JPME) at one of the various service colleges
Postgraduate education is important to the success of the Information Professional. Most IPs will complete a master's degree in C4I, space, information systems, computer science or modeling and simulation.
There's also potential to pursue a graduate certificate, DoW certifications, federal executive fellowships and information assurance scholarships and internships.
Qualifications & Requirements
A degree from a four-year college or university is a minimum educational requirement to become a Commissioned Officer. Candidates seeking an Information Professional Officer position must have a bachelor's degree from a regionally accredited institution in a technical field, preferably in one of following fields: Information Systems, Electrical Engineering, Computer Engineering, Information Operations, Computer Science, Systems Engineering, General Engineering.
All candidates must also be: U.S. citizens, willing to serve worldwide, eligible for a Top Secret/Sensitive Compartmented Information (SCI) security clearance and qualified for sea duty.
General qualifications may vary depending upon whether you're currently serving, whether you've served before or whether you've never served before.
Part-Time Opportunities
There are part-time opportunities available as an Information Professional Officer.
Serving part-time as a Navy Reserve Sailor, your duties will be carried out during your scheduled drilling and training periods. During monthly drilling, Information Professional Officers in the Navy Reserve typically work at a location close to their homes.
For annual training, Information Professional Officers may serve anywhere in the world, whether on a ship at sea or at bases and installations on shore.
Take a moment to learn more about the general roles and responsibilities of Navy Reserve Sailors.
Most of what you do in the Navy Reserve is considered training. The basic Navy Reserve commitment involves training a minimum of one weekend a month (referred to as drilling) and two weeks a year (referred to as Annual Training) - or the equivalent of that.
Information Professional Officers in the Navy Reserve serve in an Officer role. Before receiving the ongoing professional training that comes with this job, initial training requirements must first be met.
For current or former Navy Officers (NAVET): Prior experience satisfies the initial leadership training requirement - so you will not need to go through Officer Training again.
Officers who previously held a commission in another United States Military Service, National Oceanic and Atmospheric Administration, Public Health Service, or United States Coast Guard are exempt from attending ODS or LDO/CWO Academy.
Compare Navy Careers
See how a career as an Information Professional Officer compares to other Navy jobs.
Compare roles, pay and requirements for each job now.
FLSA Status: Exempt
Department: Food and Beverage Kitchen
Reports to: Chef De Cuisine & General Manager
Purpose:
The Chef is directly responsible for the cost-effective operation of a clean and safe kitchen while meeting or exceeding food quality and speed of service requirements. The Chef works as part of the management team of the restaurant to build sales and grow the business and is responsible for operating a profitable restaurant, where the quality of food, service and ambience are continually challenged and improved, and where an environment that fosters creativity, free thinking and intelligent decision-making is encouraged.
The Chef is expected to work an average of 5055 hours per week.
Essential Duties:
-Creating and maintaining an upbeat, productive, and educational environment.
- Projecting a positive attitude.
- Showing respect for all employees and actively cultivating an inclusive environment build upon
mutual respect, civility, and positivity.
- Providing ongoing training and constant improvement of product and workplace (i.e., safety,
sanitation and systems).
- Setting the pace and tone of the kitchen and overall restaurant through attitude,
initiative and drive.
- Providing feedback and direction to BOH employees, to continue ongoing development.
-Helping to develop a cohesive team and leading them to work toward the common goals of the
restaurant.
- Possessing a high level of initiative and drive to do whatever is necessary to build and run a
successful operation.
- Working closely with the General manager to create a team atmosphere among the entire staff that is both a positive and professional work environment.
- Leading by example, taking an active role in cooking and supervising the line during dinner service.
- Participate in mini meetings with FOH management on a regular basis to ensure clear line of communication and upkeep of company goals.
- Establishing clear communications along all lines within the business.
Building the Business and Guest Base
- Aggressively working to build food sales by operating the kitchen with a guest-satisfaction mentality.
- Making decisions based on what is best for the guest.
- Solving problems so that each guest will want to return.
-Working with the GM and front of house manager to train staff on product knowledge.
Quality of Operations
-The Chef is responsible for ensuring that the restaurant is operating at or above company standards. The
-Chef must pay attention to detail in all areas of the operation, including food quality and consistency, training
and development, security, safety, sanitation, and physical structure.
Specifically:
- Ensuring strict adherence to standards for food quality.
- Demonstrating commitment to cultivating knowledgeable staff members who are proud of our
quality and believe in our concept.
- Ensuring all Health Department regulations are always enforced.
Cost Management and Profitability
The Chef is responsible for generating strong financial performance for the health of the restaurant and the
company. They are ultimately responsible for ensuring that the food and BOH labor costs meet or exceed
budgeted financial goals.
Specifically:
- Working proactively with the General Manager to maximize sales and optimize profits through the
management of food and labor costs.
- Food COGS goal of 28% or less.
- Total Kitchen Labor goal of 11%
- Analyzing weekly costs to ensure proactive management of controllable costs.
- Assuming full responsibility for:
- Monitoring daily BOH labor reports and minimizing overtime.
- Providing a monthly physical inventory
- Maintaining the valuations on your inventory using invoices from vendor
- Purchasing and Receiving
- Monitoring local vendors accordingly.
- Placing effective orders, based on sales, while simultaneously taking advantage of drop size
incentives.
- Proper receiving, rotation, storage, and handling of all food products.
Production
- Taking a hands-on approach and being directly involved in daily production.
- Setting appropriate prep levels (sales versus usage) to ensure fresh product and effective use of
labor, including:
- Daily prep counts.
- Weekly prep totals and weekly prep plans.
- Regular review of Product Mix (P-Mix) information.
Personnel
The Chef is responsible for overseeing all aspects of kitchen staffing and is responsible for the hiring and
scheduling of quality employees to execute the menu successfully and to maintain the smooth flow of
kitchen operations.
Specifically:
- Establishing and maintaining appropriate staffing levels and remaining abreast of any changes that may
impact staffing needs.
- Keeping the GM informed of all staffing needs.
- Ensuring thorough and complete training of all employees, including kitchen operations, knife
safety, proper handling of product, use of chemicals, use of equipment, etc.
- Minimizing employee turnover.
- Providing coaching, mentoring and development to all employees as this is critical for the
success of the restaurant and the company.
- Mentoring, coaching and developing Sous Chef Donald Readington to be an extension of yourself. Sous
development should include; menu engineering, systems development, training systems, vendor
negotiations and kitchen management.
- Providing consistent and frequent feedback to Sous Chef(s) and staff.
- Teaching and coaching staff daily.
- Holding BOH meetings to review specials, menu items and discuss kitchen issues.
- Attending FOH Pre-Meals to review specials, menu items and discuss kitchen issues.
- Producing an accurate forecast
Administration
- Overseeing the creation and implementation of all menus.
- Ensure all menu changes are rolled out according to The Terrace Rooftop Dining procedures
- Ensuring that performance reviews of all BOH employees are completed annually
Facility and Equipment
The Chef is responsible for the daily upkeep of the physical restaurant/kitchen, specifically:
- Providing a daily walk through of the kitchen to determine areas needing attention or repair.
- Maintaining a running punch list of need to have as well as nice to have items which are
handled in a timely fashion as appropriate.
- Planning necessary upgrades in a timely, well thought out way.
- Calling appropriate repair companies
- Keeping The Terrace Leadership informed of all necessary repairs and logging repairs and
Maintenance.
This job description is not an exclusive or exhaustive list of all job functions that an associate in this position may be asked to perform from time to time.
Compensation details: 75 Yearly Salary
PI152e172c56af-26289-39969973
Notice: MCRA’s Talent Solutions division works to unite top talent with opportunities on our clients’ teams. This posting is not for a position directly at MCRA, but rather for a position with a MCRA client that our team is helping to recruit and fill.
MCRA's client, a commercial-stage medical device company specializing in designing, developing, and marketing orthopedic fracture repair and stabilization products, is in search of a Director of Quality and Regulatory Affairs to provide support across Regulatory, Quality Assurance, Operations, and Research & Development (R&D).
Primary Roles:
- Is a key member of the senior leadership, and is responsible for the successful operation of the company's quality and regulatory systems. Essential functions include the development, implementation, maintenance, and improvement of company-wide quality and regulatory systems, integrating continuous improvement activities.
- Serves as our clients Management Representative under ISO and FDA requirements, and takes the lead role in ensuring that the quality management system is efficient, effectively implemented and ensures compliance with the requirements of applicable regulatory agencies. Responsible for the generation and maintenance of our client's Quality systems, with direct oversight for the processes for Complaints Management, CAPA, Risk Management, Post-Market Surveillance, and Regulatory Reporting.
- Is responsible for leading the resolution of quality and compliance issues within the business and provide routine quality feedback and leadership to cross-functional groups
- Serves as the official correspondent to Competent Authorities (e.g. FDA, EU countries, etc) as well as Notified Body. Responsible for maintaining compliance registrations and device listings.
- Ensuring compliance with FDA and other applicable international regulations and requirements for the design, development, distribution, and maintenance of medical devices and provide general regulatory support to the organization
Responsibilities:
Quality Systems
- Provide operational leadership in planning and management of quality system activities to maintain appropriate QMS certification
- Responsible for leading and interfacing with any Notified Bodies or Competent Authorities during inquiries or facility inspections by such organizations
- Acts as lead in all product complaint and recall campaigns.
- Responsible for interfacing with and following up with any Customers regarding complaints
- Responsible for Supplier Quality assurance program
- Responsible for Measurement, analysis and improvement programs, including quality trending, CAPA system, and the Internal Quality Audit program for our client.
- Leads the Management Review process
Quality Engineering
- Ensures all inspection and quality plans are statistically sound and can ensure quality levels that exceed requirements
- Ensures all device history records are complete and reviewed prior to release of product
- Assist suppliers by providing information to enable process improvements
- Ensure all manufactured products are conforming to FDA Quality System, ISO 13485, MDD, and MDR
- Supports the engineering staff with PPQA activities, validations, and statistical analysis of new products and processes
- Leads Risk Management and Post-Market Surveillance activities
Regulatory Affairs
- Develop and implement global regulatory and compliance strategies to:
- Ensure all products designed, manufactured and/or shipped meet all regulatory, corporate and customer requirements for quality, safety and efficacy;
- Ensure proper and timely preparation and maintenance of national and international new product submissions, registration/licensing renewals, product listings, post market surveillance reports, import and export documents, safety testing, and other national and international requirement
- Optimize and focus on quality during the design and change control processes for both new and existing products;
- Ensure all advertising and promotion materials conform to applicable FDA, EU, and, where applicable, other country regulations.
- Responsible for the CE Mark approval process for all products, and Technical File generation and maintenance
- Responsible for writing Letters to File as required
- Participates in the development and writing of 510(k) submissions with the management team utilizing external resources as required
- Responsible for external agency reporting
Education:
- Bachelor’s Degree in Engineering or Natural Science preferred, coupled with approximately 10 years of combined experience in QA / RA in the medical devices industry; experience regarding medical device design, development and manufacturing regulations, especially 21 CFR Part 820 Quality System Regulation, the MDD and MDR Directives, as well as ISO 13485 requirements. 5 years of experience managing supervisory personnel and contributing toward the development of department strategies.
Experience/ Skills:
- Ability to build efficient quality assurance systems; including electronic document and record control, CAPA, NCR, complaint, training, metrics
- Demonstrated ability to write, review, execute and critique validation protocols, investigation plans, root cause analyses, NCRs, CAPAs, complaints, trend report
- Has experience with applying ISO 14971 principles to medical devices throughout all stages of the product's lifecycle.
- Demonstrated leadership skills and team building skills, inspires others toward continuous quality improvement
- Able to solve complex quality, technical, managerial or budgeting problems
- Readily adapts to changing priorities, effectively manages own time and direct reports to ensure tasks, projects are completed on time to meet growth objectives. Adjusts easily and readily to a fast-paced work environment
- Working knowledge of data acquisition, analysis and statistical software
- Demonstrated ability to manage multiple projects and technical personnel simultaneously
- Successful oral and written communication skills, business acumen and assertive decision-making ability
- Excellent computer skills, including MS Office proficiency
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as to meet the ongoing needs of the organization.
MCRA, LLC is an equal opportunity/Affirmative Action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.