Lead Quality Assurance Engineer

2 weeks ago

Chicopee, Massachusetts, United States UFP Technologies Full time


About UFP Technologies:

UFP Technologies specializes in designing and manufacturing tailored solutions for medical devices, sterile packaging, and other highly engineered custom products. As a crucial component in the medical device supply chain, UFP serves as a trusted outsourcing partner for many leading medical device manufacturers globally. The company’s single-use and single-patient devices and components are integral to a variety of medical applications, including minimally invasive procedures, infection control, wound management, wearable technology, orthopedic soft goods, and implants.

UFP Technologies, Inc. provides a comprehensive benefits package, which includes:

  • Medical, Dental, Vision, Life, and Disability Insurance
  • 401K plan with matching contributions
  • Paid time off, holidays, employee discounts, and additional perks

Position Overview: The Lead Quality Assurance Engineer is responsible for the establishment and execution of quality systems for sealed plastic film products within an ISO 13485 framework. This role is essential in ensuring that products adhere to rigorous quality and regulatory standards across various sectors. The Lead Quality Assurance Engineer will possess extensive knowledge of quality management systems, regulatory compliance, and manufacturing processes pertinent to medical devices.

Key Responsibilities:

  • Manage and approve validation protocols (IQ, OQ, PQ), including execution and reporting for both new and existing products.
  • Oversee PPAP activities and prepare submittal packages for new and existing products.
  • Supervise the Quality Technician team.
  • Contribute as a member of the FMEA team, focusing on new and developing products.
  • Develop and document control plans.
  • Conduct statistical capability studies and establish SPC control charts.
  • Document inspection procedures and testing methodologies.
  • Perform regular audits of processes and materials to ensure compliance with specifications and standard operating procedures.
  • Authorize the release of finished products based on audit findings.
  • Monitor and analyze SPC charts to maintain process control.
  • Engage directly with production teams during operator training on quality matters.
  • Review reject reports and initiate corrective actions as necessary.
  • Collaborate with other departments as required.
  • Conduct specialized testing for failure analysis and validations.
  • Set up inspection and testing equipment.
  • Develop and maintain Standard Operating Procedures.
  • Create protocols, perform statistical analyses, and write reports for validations and formal product/process development.
  • Review and document changes to procedures for quality requirements and compliance.
  • Provide support during third-party audits, customer audits, and internal audits.
  • Offer technical guidance and mentorship to quality and manufacturing engineers.
  • Adhere to all safety regulations and procedures.
  • Follow departmental and company policies and procedures.
  • Perform additional duties as necessary based on responsibility and necessity.

Qualifications:

  • Bachelor’s degree in a related field.
  • Minimum of 3 years of experience in a Quality Engineering role, preferably within medical device manufacturing.
  • At least 3 years of experience in validation activities oversight (IQ, OQ, PQ, MSA), PPAP package submittals, FMEA/PFMEA participation, Root Cause Analysis/CAPA, Internal Quality Audits, Supplier Quality, and Software Validation.
  • Strong knowledge of ISO 13485, PPAP, FMEA, AIAG Control Plan Methodology, SPC, and Good Manufacturing Practices.
  • ASQC Certified Quality Engineer certification is preferred.
  • Proficient in Microsoft Office and other productivity software.
  • Ability to communicate effectively across all organizational levels and with suppliers.
  • Strong analytical skills for problem analysis and resolution.
  • Demonstrated leadership capabilities.
  • Willingness to travel occasionally.

For more information about UFP Technologies, please visit our website.

UFP Technologies, Inc. is an Equal Opportunity/Affirmative Action employer. We welcome applications from minorities, women, veterans, and individuals with disabilities.

#UFP #MEDTECH #QUALITY #ENGINEERING

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