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Senior Quality Engineer

1 month ago

Chicopee, United States UFP Technologies Full time


About UFP MedTech:

UFP Technologies is a designer and custom manufacturer of comprehensive solutions for medical devices, sterile packaging, and other highly engineered custom products. UFP is an important link in the medical device supply chain and a valued outsource partner to most of the top medical device manufacturers in the world. The Company's single-use and single-patient devices and components are used in a wide range of medical devices and packaging for minimally invasive surgery, infection prevention, wound care, wearables, orthopedic soft goods, and orthopedic implants.

UFP Technologies, Inc. offers a competitive benefits package, including but not limited to:

  • Medical, Dental, Vision, Life, Disability Insurance
  • 401K with a matching contribution
  • Paid time off, Paid holidays, Employee discounts and much more

Location: This position will be on-site full-time in Chicopee, MA. The position holder will need to be within commuting distance (within 45 min).

Qualified applicants must be eligible to work in the United States to be considered for this opportunity. Employment based visa sponsorship (including H01B sponsorship) is not available for this position.

Senior Quality Engineer Summary:

The Senior Quality Engineer has the responsibility for the development and implementation of quality systems for sealed plastic film products in an ISO 13485 environment. This role will ensure that these products meet stringent quality and regulatory requirements across multiple industries. The Senior Quality Engineer will have a deep understanding of quality management systems, regulatory compliance, and manufacturing processes related to medical devices.

Senior Quality EngineerEssential Duties and Responsibilities:
  • Oversees and approves IQ, OQ, PQ validation protocols, execution and reports on new and sustaining products.
  • Oversees PPAP activities and produces PPAP submittal packages on new and sustaining products.
  • Oversees Quality Technician function.
  • Participates as a member of the FMEA team related to primarily new and developing products.
  • Develops and documents control plans.
  • Conducts statistical capability studies and sets up SPC control charts.
  • Documents inspection procedures and test methods.
  • Performs regular audits of processes and materials to ensure that: Inspections, tests, and operations are being conducted and documented according to applicable specifications and standard operating procedures. Assures results of inspections and tests are in compliance with all applicable requirements.
  • Finalizes release of finished product based on above audits.
  • Monitors and interprets SPC charts to assure that processes remain in control.
  • Interfaces directly with production in the operator training process for quality issues.
  • Reviews reject reports and initiates corrective action as required.
  • Interfaces directly with other support departments as required.
  • Conducts special testing when required for failure analysis, validations, etc.
  • Sets up inspection / test equipment.
  • Develops and maintains Standard Operating Procedures.
  • Develops protocols, performs statistical analyses and writes reports for validations and formal product / process development.
  • Reviews and documents procedure changes for quality requirements and compliance with the quality system.
  • Provides audit support for third party audits, customer audits, and internal audits.
  • Provides technical guidance to the staff and mentorship to quality and manufacturing engineers.
  • Observes all safety regulations and procedures.
  • Follows all department and company policies and procedures.
  • Performs other similar duties as required by responsibility, necessity or as requested.
Senior Quality Engineer Qualification Requirements:
  • 4-year college degree in related field.
  • 3+ years' experience in a Quality Engineering Role (preferably in medical device manufacturing).
  • 3+ years' experience in the following: Oversight and approval of validation activities (IQ, OQ, PQ, MSA), oversight of and submittal of PPAP packages, participation in FMEA/PFMEA activities, Root Cause Analysis / CAPA, Internal Quality Audit, Supplier Quality, and Software Validation.
  • Good working knowledge of ISO 13485, PPAP, FMEA, AIAG Control Plan Methodology SPC, and Good Manufacturing Practices.
  • ASQC Certified Quality Engineer, preferred.
  • Proficiency in the use of Productivity Software such as Microsoft Office.
  • Ability to interact with all levels of the organization and with suppliers.
  • Strong written and oral communication skills.
  • Strong analytical skills in problem analysis and problem solving.
  • Strong leadership skills.
  • Occasional travel may be required.

To apply for this job please create a profile with us through our online application system. Click the "Apply" box in the upper right-hand corner to start the application process. Or, if you already have a social media account with LinkedIn, Google, or Facebook you can use your log in credentials to apply.

For more information on UFP MedTech, visit www.ufpmedtech.com.

UFP Technologies, Inc. is an Equal Opportunity/Affirmative Action employer Minorities/Women/Veterans/Disabled.

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