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Quality Engineer - Supplier Quality

Bryn Athyn, PA 19009

Posted: 09/12/2023 Employment Type: Direct Hire/Perm Job Category: Engineering Job Number: 572754 Is job remote?: No Country: United States

Job Description

Essential Functions
Responsible for coordinating supplier qualification, approval and management and verifying quality standards in accordance with FDA, ISO, MSBUS requirements and other regulations.  Manage the Supplier Quality process working with External Manufacturing ensuring the Supplier Quality, Non-conformances/deviations and Change Controls from suppliers are managed appropriately. 
  1. Create and maintain Supplier Quality Files including Supplier Qualifications, Questionnaires, Supplier Certifications and Quality Agreements.
    • Track and qualify (or disqualify) suppliers according to MSBUS standards.
    • Report supplier performance and quality to management.
    • Identify technical problems with suppliers and support the implementation of corrective actions.
    • Support and assist in establishing and maintaining new supplier processes as needed.
    • Maintain and update Approved Suppliers List (ASL) as needed.
  2. In collaboration with the Supply Chain function, Support the development of new Quality Agreements working and coordinating with External Manufacturing and Supplier representatives to obtain final approval and proper implementation
  3. Draft and develop new SOP’s and revise/update existing SOP’s as needed.
  4. Support and conduct Internal and Supplier Audits coordinating with qualified MSB auditors where required.
  5. Support the Complaint handling process working with Quality Management ensuring the complaints -particularly supplier related-  are properly entered into the system in a timely manner including the accuracy and completeness of records.
    • Work closely with domestic and international service/complaint handling organizations, Field Service Engineers and company SME’s to gather more information to resolve open issues.
    • Identify and escalate emerging quality issues, potential risks, and trends including PHS events requiring further investigation and review by Regulatory Affairs.
  6. Utilize Documentum for managing new documents and revisions to existing documents.
  7. Manage and document significant supplier related issues in TrackWise where required.
  8. Support and generate quality trend data from supplier audits and non-conformances and complaints for use in periodic updates and as part of the scheduled management reviews or in support of other objectives.
  9. Support and actively participate in third party audit and regulatory inspection activities.
  10. Support functional requirements for Deviations and non-conformances, change controls and CAPAs within TrackWise. 
  11. Support process and design validation activities partnering with Validation Specialist, QC, Operations, R&D and third parties.
  12. Perform other quality related duties as assigned.
  13. Must embody the company’s Vision, Mission and Values.
General Competencies:
  • Quality systems in a regulated healthcare environment
  • Technical & Business acumen
  • Strong problem solving/analytical skills
  • Thoroughness and detail-oriented
  • Excellent Written/Verbal communication skills
  • Demonstrates prioritization and time management skills
The Quality Engineer is an individual contributor position working cross-functionally within QA and other  departments to maintain compliance with the regulatory and quality system requirements including FDA QSR and ISO 13485. 
Work Environment
This job operates in a typical office setting, requires use of computer.
Physical Demands
This is an office-based position which will some activities in a production environment as well as with suppliers off-site.
Position Type/Expected Hours of Work
This is a full time, exempt, professional-level position. Typical days and hours of work are Monday through Friday, 8:30 a.m. to 5:00 p.m.; this position may be eligible for hybrid work arrangements for qualified candidates.
This position involves  limited travel; domestically and/or internationally.
Required Education and Experience
  • Bachelor’s degree or two year associates degree with relevant experience.
  • Minimum of 3 to 5 years of experience in a medical device or regulated industry.
  • Basic understanding of Supplier Quality functions including Supplier Audits, CAPA, Deviations/Non-conformances and quality engineering.
  • Management and/or experience in conducting Internal Audits and Supplier Audits.
  • Certification as an Internal Auditor and/or QE is desired.
  • Familiar with medical device regulations, requirements, and standards such as 21 CFR Parts 820 and ISO 13485.
  • Must be able to work independently and effectively as part of a team exhibiting effective interpersonal skills.
  • Proficient with MicroSoft Office tools such as excel spreadsheets and Microsoft Word. 
  • Experience working with electronic Quality System management and Document Management tools such as TrackWise and Documentum.

salary range: $95-$110k 
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