65 applicants
KMC Systems, Inc. · 5 days ago
Senior Production Quality Engineer
Merrimack, NH
Full-time
Onsite
Senior Level
5+ years exp
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Responsibilities
Assure Quality Assurance programs and plans are in place to provide and maintain the highest quality levels for an assigned project, product or area.
Recommend and implement methods and procedures for evaluating the precision and accuracy of assigned products or production equipment.
Provide QMS support to inspection and operations personnel and establish workmanship criteria for projects.
Evaluate non-conformance containment, disposition and product impact. Write technical and risk-based customer notices.
Perform root cause analysis and determine appropriate corrective and preventive actions and effectiveness criteria as required.
Analyze statistical data to evaluate trends, investigate failures completely to determine the root cause and take appropriate corrective action to prevent recurrence.
Identify and correct instrumentation malfunctions, re‑designing or modifying complex test equipment, devising advanced applications of engineering technology to solve problems.
Review test techniques and methods for testing company products or components on the basis of product specifications and manufacturing processes.
Oversee qualification and periodic testing requirements, initiating required customer reports and leading corrective action efforts on failures/defects.
Qualification
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Required
BS degree preferred plus 5 or more years of related experience to be proficient in the above areas; or an equivalent combination of education and experience.
Prior experience in Medical Device or Pharmaceutical manufacturing support. FDA and ISO audit experience (13485, 21 CFR 820, 803, 806 and 14971) is preferred.
Strong, demonstrated ability to provide technically sound Quality Assurance and Quality System solutions to designated programs to achieve business results and maintain high levels of quality and compliance.
Robust and flexible communication skills. Demonstrated experience working with contract manufacturing, suppliers and customers is desired.
Preferred
Green Belt/Black Belt proficiency desired or CQE.
Benefits
Competitive compensation & 401k program
Robust medical, dental, vision, & disability coverage with qualified wellness discounts
Basic Life Insurance and Additional Life & AD&D Insurances are available
Flexible Vacation & PTO
Paid Parental Leave
Generous Employee Referral Program
Voluntary Benefits Available: Longer Term Care, Legal, Identify Theft, Pet Insurance, and many more options
Voluntary Tricare Supplement available for military retirees
Company
KMC Systems, Inc.
KMC Systems is a trusted partner for engineering and manufacturing complex, automated, full-system instrumentation for the medical and life sciences markets.
201-500 employees
H1B Sponsorship
KMC Systems, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (3)
2021 (1)
Funding
Current Stage
Growth StageRecent News
2022-03-10
Company data provided by crunchbase
