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Quality Assurance Manager

Cambridge, MA 02138

Posted: 09/05/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 614014 Is job remote?: No Country: United States

Job Description

Target PR Range: 45-55/hr
*Depending on experience

This role provides quality oversight with regards to the development and lifecycle management of test and inspection methods and fulfillment of regulatory commitments. Potential scope of products with regards to test and inspection methods includes a wide range of devices, raw material components, and constituent parts, such as; needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems. The qualified candidate will both lead and/or support technical teams to ensure successful method development or remediation and/or fulfillment of regulatory commitments, provide quality oversight to one or more cross-functional teams to utilize technologies and methodologies that support short-cycle robust development, accelerated compliance efforts, and/or remediation/improvement opportunities. The Quality Assurance Manager will also provide Quality oversight of quality records such as Deviations, CAPAs, Change controls and review/approval of physical test methods documents.

Responsibilities:
* Work cross-functionally and globally with individuals and project teams within Combination Product Operations Quality and Combination Product Operations groups and their stakeholders in Marketing, Operations, and Development
* Ensure compliance to design controls and fulfillment of user needs during test or inspection method development or design changes, including proper and compliant integration of different subsystems as required.
* Provide quality oversight and guidance regarding the development of process control plans and implementation of process improvements/changes.
* Work with cross-functional teams to develop, qualify, and transfer physical test or inspection methods.
* Provide comprehensive quality guidance and advice to counterparts and stakeholders.
* Provide Quality oversight of quality records such as Deviations, CAPAs, Change controls and review/approval of physical test methods documents.

Skills: BS or BE in Engineering and previous experience in the medical device and/or pharmaceutical industries
- 8 years current experience with engineering processes/procedures and quality tools. - Major contributions to or the leadership of projects from development through the 510k and PMA approval process.
- Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification/validation, DOE/SPC process optimization & validation (IQ, OQ, PQ), P/DFMEA.
- Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
- Experience in test or inspection method design and development - Small scale device assembly and/or benchtop testing experience.
- Experience with Automated Test Equipment (ATE). – Experience with regard to Measurement Systems Analysis/GRR principles, including study design/execution/troubleshooting
- Experience with Deviations, CAPAs, Change controls and document review/approval
- Strong critical thinking, problem solving, risk assessment, and risk management skills.
- Must be capable of working on multiple projects in a deadline driven environment.
 

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 Cambridge, MA

Calling all job seekers! Discover exciting job opportunities in and around Cambridge, Massachusetts, a vibrant city known for its rich history, world-renowned universities like Harvard and MIT, and innovative tech scene. Cambridge offers a unique blend of academic excellence, cultural diversity, and a thriving arts community, with attractions like the iconic Harvard Square, the charming Charles River Esplanade, and the prestigious American Repertory Theater. From savoring local specialties like clam chowder and lobster rolls to cheering on the Red Sox at Fenway Park, there's something for everyone in this dynamic region. Explore job listings today and kick-start your career in this captivating area!

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.