NPI Quality/Validation Engineer
Full-time
Merrimack Manufacturing
Position Overview:
This position supports design transfer activities and quality operations in an innovative, fast-paced, medical device-manufacturing environment. This role includes generation and maintenance of control plans, risk management files, validation protocols, and other QMS documentation to support initial qualification and launch of commercial production activity. The role will also provide support to the organizational goals by leading improvement projects to increase efficiency and compliance across the site. Responsibilities:
This position supports design transfer activities and quality operations in an innovative, fast-paced, medical device-manufacturing environment. This role includes generation and maintenance of control plans, risk management files, validation protocols, and other QMS documentation to support initial qualification and launch of commercial production activity. The role will also provide support to the organizational goals by leading improvement projects to increase efficiency and compliance across the site. Responsibilities:
- Leverage your engineering and technical experience to evaluate new products, manufacturing processes and ensure compliance with applicable regulatory standards throughout the New Product Introduction process
- Provide input to the development, review, and update of User Requirements, critical quality attributes, and other design documentation
- Lead project teams through validation protocol generation, execution, documentation organization, report writing, etc. while meeting schedule for final approval and release
- Conduct investigations resulting in root cause and corrective actions through use of data analysis, inductive and deductive reasoning, and problem solving skills
- Lead the evaluation and identification of validation requirements and sampling plans for new, and changes to, manufacturing processes, test methods, and equipment
- Develop inspection procedures and sampling plans for new production, continuous improvement of process controls, and improved workflow/worker satisfaction
- Assist in the development, implementation, and approval of Device Master Records, Device History Records, and Risk Management Files for new products
- Provide guidance and assistance on the assessment of new and changes to existing manufacturing equipment, ensuring proper enrollment into QMS systems and that Validation requirements are met
- Lead improvement projects to increase efficiency and compliance within Merrimack Manufacturing’s Quality Management System
- Contain defective product and processes systemically, participate in Material Review Board (MRB) meetings, track and follow through with nonconformance investigations assigned to internal and external team members.
- Support and contribute towards the success of external audits, whether conducted by the FDA, a Notified Body, other regulatory bodies, or external customers
- At least 3 years of experience in Medical Device Manufacturing or other similarly regulated industry such as Aerospace, Military, etc.
- Strong knowledge of CFR Part 820 and ISO 13485 required
- Lean or Six Sigma certification preferred
- Strong knowledge of IQ/OQ/PQ requirements, measurement system analysis, and supporting engineering specifications
- Knowledge of Design Transfer and introduction of new product processes and deliverables
- Strong knowledge of tolerance stack up calculations and calibration best practices
- Strong organization, communication, and time management skills; Project Management experience preferred
- Knowledge of industry standards and best practices for Software Validation, Controlled Environments, Biocontamination Controls, and Gamma Irradiation also preferred
Vacancy posted a month ago
Similar jobs that could be interesting for youBased on the NPI Quality/Validation Engineer in Manchester, NH vacancy
- ...supports design transfer activities and quality operations in an innovative, fast-paced... ...control plans, risk management files, validation protocols, and other QMS documentation... ...Responsibilities: Leverage your engineering and technical experience to evaluate new...Suggested
Merrimack Manufacturing
Manchester, NH12 days ago - ...(onsite 5 days a week) Senior Supplier Quality Engineer for a medical device company in Southern... ...across both New Product Introduction (NPI) and sustaining manufacturing operations... ...for NPI programs, including process validation support, and onboarding of new suppliers...SuggestedPermanent employmentFull timeContract workRemote work
- ...pioneer and shape the future of PCI.Summary of Objective:The Validation Engineer IV performs an array of well-defined validation activities... ...functionally with Manufacturing, Engineering, Critical Utilities, Quality Assurance, and project management to achieve all project...SuggestedFull timeContract workWork experience placementWork at office
- ...Verification & Validation Test EngineerDEKA Research & Development, located in Manchester,... ...seeking a Verification & Validation Test Engineer to work in a dynamic medical device R&D... ...regulatory and agency submissionsAuthoring Quality Plans, Test Summaries, and other...Suggested
DEKA Research & Development
Manchester, NH2 days ago - ...Supplier Quality EngineerThe Supplier Quality Engineer is responsible for leading supplier quality activities during... ...transfer and process/product validation. This role ensures supplier compliance... ...managementExperience supporting NPI or design transfer activities strongly...SuggestedContract work
DEKA Research & Development
Manchester, NH5 days ago - ..., has an immediate opening for a Junior Verification & Validation Test Engineer to work in a dynamic medical device R&D environment. Test Engineering... ...skills Experience in medical devices, knowledge of FDA Quality System Regulations (QSRs) and/or ISO 13485, and other...Full timeImmediate start
DEKA Research & Development
Manchester, NH4 days ago $85k - $100k
...Job Description Job Description Power Quality Engineer (Remote Position) Role Summary We are seeking a Power Quality Engineer with a specialized focus on electrical power quality diagnostics and data analysis. In this role, you will analyze raw power quality...Remote workFlexible hoursAvtron Power Solutions, LLC
Manchester, NH5 days ago- DEKA Research and Development in Manchester, NH seeks a Junior Verification and Validation Test Engineer to join a medical device R&D team. The role offers high visibility, with a direct impact on project success through hands-on testing of interfaces and hardware. You...
$65k - $90k
...Manchester, NHAbout the RoleOur facility is set to double in size over the next 2-3 years, driving an expansion of our engineering team. We are hiring two Quality Engineers (Level I or II) reporting directly to the Director of Quality.We have a GREAT culture. We maintain a...InternshipWork at office- ...Quality Systems EngineerJoin our dynamic team at DEKA and be at the forefront of driving quality excellence! As our Quality Systems Engineer, you'll be a key player in our collaborative environment, working hand-in-hand with cross-functional teams to ensure the highest...
DEKA Research & Development
Manchester, NH2 days ago - ...Join A Well-Established Engineering And Manufacturing BusinessThis organization is a well-established engineering and manufacturing business... ...and customer requirements. Develop, maintain, and improve quality procedures and systems to ensure full compliance with standards...Permanent employmentLocal area
Michael Page
Manchester, NH5 days ago - ...Quality Control InspectorPosition SummaryReads and interprets work instructions, blueprints, and customer and industry specifications and requirements to determine dimensions, tolerances, and requirements. Completes source inspection tasks as assigned. Provides support...
Granite State Manufacturing
Manchester, NH3 days ago - ...Job TitleJoin a well-established engineering and manufacturing organisation known for delivering highly technical products for demanding... ...products and manufacturing processes meet customer requirements and quality standards. Review drawings, specifications, quality...Work at officeLocal area
Michael Page
Manchester, NH5 days ago - ...Job TitleSupport cleaning validation activities, protocol execution, sampling, and documentation.Perform temperature mapping and requalification... ...equipment.Assist with equipment troubleshooting alongside Engineering and Operations.Generate validation documentation following...
Katalyst HealthCares & Life Sciences
Manchester, NH2 days ago - ...capabilities to meet increasing demand and to expand into new markets and antenna technologies. Haigh-Farr is seeking a Quality Engineer with a demonstrated background in roles where a high attention to detail were required. The successful candidate will be responsible...Work experience placementFlexible hours
Haigh-Farr Inc
Bedford, NH12 days ago - ...OVERVIEW: This positon will help manage and improve the overall quality of our supply chain partners, and help ensure that we are... ...and will work extremely closely with our Incoming Inspection, Engineering and Material Management team. This role will be the primary driver...Work at office
Merrimack Manufacturing
Manchester, NH12 days ago - ...vertically integrated provider of highly engineered, high-reliability, and high-performance... ...world-class reputation for innovation, quality products and expertise, and outstanding... ...-process inspections, and final product validation Support internal and external audits,...Full timeTemporary workWork at officeFlexible hours
RCD Components
Manchester, NH4 days ago - ...This position will support manufacturing quality operations in a dynamic, fast-paced,... ...devices for design verification, design validation, and commercial production. RESPONSIBILITIES... ...and devices Use experience with engineering and technology to ensure compliance...Work at office
Merrimack Manufacturing
Manchester, NH12 days ago - ...is looking for a technically deep, process-driven Software Quality Assurance Engineer to join our cloud engineering team. This is an individual... ...Specifications (SRS), Software Design Documents (SDD), Verification & Validation Plans and Reports, and Software Risk Management Files...
DEKA
Manchester, NH1 day ago - ...Eversource Energy is seeking a Transmission and Substation Engineer to ensure asset reliability while controlling costs. The role emphasizes asset planning, performance measurement, and cross-functional collaboration across transmission functions. Responsibilities include...
Eversource Energy
Manchester, NH4 days ago - ...medium volume production , delivering precision, quality, and on-time performance on custom-engineered products. Our capabilities include: Large-... ...well as First Article Inspections (FAI), process validations, and qualification activities. ~ Supports programs...Contract workWork at officeLocal areaFlexible hours
Granite State Manufacturing
Manchester, NH5 days ago - ...components into finished assemblies while championing documentation, quality, and safety.Your missionTurn plastic and metal parts into... ...conditions immediately and inform your supervisor.Collaborate with Engineers and line leads to resolve issues and optimize procedures for...Immediate start
- ...check sheets and production reports. Ideal candidates have about 2 years in manufacturing, strong communication, and the ability to work closely with Engineers and line leads in a fast-paced environment while adhering to GMP, ISO, and FDA #J-18808-Ljbffr Torrey Holistics
- Job Title: Sr. Associate, Supplier Quality EngineerJob Code: 39244Job Location: Londonderry... ...:In this role, the Supplier Quality Engineer (SQE) will support and interface across... ...generation and review of requirements, and validate flow down of expectations. The SQE will...For subcontractor
- ...The Plant Quality Engineer (PQE) - Responsible for all aspects of product conformity for their systems / Components at the Warren Truck... ...Additional responsibilities include but are not limited to: Validating product changes, providing technical expertise, and...Hourly payFull timeImmediate start
Stellantis
Manchester, NH5 hours ago - Job Title: Senior Associate, Quality Engineering (Londonderry, NH)Job Code: 38168Job Location: Londonderry, NHJob Schedule: 9/80: Employees... ...corrective action follow-up with internal stakeholders.Verify and validate products and processes to confirm conformance to engineering...Immediate start
- Job Title: Sr. Industrial Operations Engineer - Front Loading NPI Job Code: 41430Job Location: Londonderry, NHJob Schedule: 9/80: Employees work... ...Front Loading methodologies to ensure manufacturability, quality, and cost targets are achieved while maintaining schedule...
- ...to be part of an inclusive, adaptable, and forward-thinking organization, apply now.We are currently seeking a QA Automation SDET Engineer (Onsite/FTE) to join our team in Merrimack, New Hampshire (US-NH), United States (US)."Please note that we are unable to consider...Work at officeRemote workFlexible hours
- ...Supplier Quality EngineerSpyglass Partners LLC has over 20 years of experience as a nationwide staffing firm and is your ideal source for all your project-based temporary and direct-hire staffing needs. Spyglass Partners excels in placing contract and direct-hire resources...Contract workTemporary work
Spyglass Partners LLC
Merrimack, NH5 days ago - ...Hudson, NH Description: Reporting to the Quality Manager, the Quality Engineer will be located at the Hudson, NH corporate facility. This position will be responsible for all aspects of Quality Engineering within the company including the following: Maintain...
kSARIA
Candia, NH3 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to NPI Quality/Validation Engineer. Be the first to apply!
Related searches
- quality systems engineer Manchester, NH
- supplier quality engineer Manchester, NH
- customer quality engineer Manchester, NH
- quality engineer Manchester, NH
- quality management nurse Manchester, NH
- supplier quality Manchester, NH
- quality improvement nurse Manchester, NH
- water quality Manchester, NH
- quality equipment Manchester, NH
- quality intern Manchester, NH