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Quality Manager, Medical Devices

Franklin Ctr, PA 19341

Posted: 09/15/2023 Employment Type: Contract Job Category: QA/Automation Job Number: 585949 Is job remote?: No Country: United States

Job Description


Target Pay Rate: 60-68/hr **salary will be commensurate with experience 

Job Summary:

Develop and implement quality program with specific emphasis on Quality Systems, Verifications and Validations, Audits, Vendor Management, CAPA's, Complaint Handling and New Product Introduction for Combination Products. Ensure compliance to relevant Quality System Regulations for all quality system processes and procedures.

Provide direction and support for the CAPA process to ensure effective root cause corrective action is implemented to address nonconformance. Interface with all levels of management, functional areas and customers as they relate to CAPAs and the CAPA process.

Ensure robust execution of the complaint systems, MDR's (medical device [vigilance] reporting), internal documents and procedures in accordance with established by regulation/procedures.

Essential Functions:
  • Develop and manage quality system in support of combination products/medical devices for client 60%
  • Provide Quality Person in Plant support for products manufactured by client and contract facilities. 10%
  • Provide quality support for Deviation Investigations and CAPA Management; Change Management, Contract Organization Approval/Monitoring Management and Complaints. 10%
  • Perform additional quality support as needed. 10%
  • Perform audits of External suppliers as needed. 10%

Requirements:
  • A Bachelors degree in Life Sciences/Engineering discipline is required.
  • Minimum 5 years experience in FDA or equivalent regulated industry (medical devices, biotechnology, or pharmaceutical industry).
  • Minimum 4 years performing Quality Assurance functions related to medical devices/combination products, and minimum 2 years of experience performing audits for medical devices/combination products.
  • Strong working knowledge of FDA, EMEA and JP regulations as they pertain to combination products/medical devices.
  • Strong verbal and written communication skills both verbal and written
  • Prior electronic systems knowledge required? (i.e., LIMS, Trackwise, SAP, MS Office, etc.)
  • Domestic and International travel required

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Franklin Ctr, PA

Ready to take the first step towards a fulfilling career in Franklin Center, Pennsylvania? This vibrant area, nestled in the heart of beautiful Bucks County, offers job seekers a unique blend of opportunities for growth and success. From its close proximity to iconic attractions like the historic Fonthill Castle and the bustling Peddler's Village, to its thriving arts scene featuring the James A. Michener Art Museum and the Bucks County Playhouse, Franklin Center is a hub of culture and charm. With delectable local cuisine, picturesque parks like Peace Valley Park for outdoor enthusiasts, and easy access to Philadelphia's professional sports teams and renowned venues, this region promises an enriching career experience like no other. Explore our job listings now and discover the endless possibilities waiting for you in Franklin Center, Pennsylvania!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.