Support the Director of Quality Assurance, and staff in maintaining supplier compliance. Maintain audit support to commercial and development activities in North America. Comply with U.S. and international regulations and standards as they apply to products manufactured in the United States and distributed to the U.S.,China, Singapore, Canada, and Europe.
location: Huntingdon Valley, Pennsylvania
job type: Permanent
salary: $75,000 - 80,000 per year
work hours: 9 to 5
- Oversee the Supplier Quality process working with External Manufacturing ensuring the Supplier Quality, Non-conformances/deviations and Change Controls from suppliers are managed appropriately.
- Maintain Supplier Quality Files including Supplier Qualifications, Questionnaires, Supplier Certifications and Quality Agreements.
- Develop new Quality Agreements working and coordinating with External Manufacturing and Supplier representatives to obtain final approval and proper implementation
- Develop new SOP's as needed.
- Manage the Internal and Supplier Audit function coordinating and conducting audits utilizing qualified auditors where required.
- Utilize Documentum for managing new documents and revisions to existing documents.
- Utilize and manage supplier related issues in TrackWise where required.
- Generate quality trend data from supplier audits and non-conformances for use in periodic updates and as part of the scheduled management reviews or in support of other objectives.
- Support field actions/recalls as necessary.
- Support the deviation/nonconformance and corrective and preventive action activities for both product and process related issues.
- Support process and design validation activities partnering with QC, Operations and R&D.
- 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,
- Management and/or experience in conducting Internal Audits and Supplier Audits.
- Familiar with medical device regulations, requirements, and standards such as 21 CFR Parts 820, 803, and 806 and ISO 13485.
- Proficient with excel spreadsheet and data analytics tools
- Fundamental understanding of quality methods, tools, and concepts.
- Experience working with TrackWise or other Quality System tracking tools.
- Experience working with electronic document management systems
skills: Quality Assurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.