Piper Companies is seeking a Quality Engineer for a large clinical development company in King of Prussia, Pennsylvania (PA). The Sr. Quality Engineer will plan, coordinate, and manage the quality assurance (QA) activities associated with product development project to ensure compliance to internal and external requirements during the development and commercialization of products.
Responsibilities for the Quality Engineer:
- Represent Quality on product development teams to ensure adherence to company quality procedures and applicable US and OUS regulatory requirements and standards.
- Lead teams for Risk Management activities for new and/or modified products and processes which includes risk assessment occurs in the appropriate phase of the project, authoring risk management plans and reports, facilitating risk assessment activities with no guidance required.
- Leads cross functional team on how to documents changes, using a risk based approach for determining requirements. Review and provide risk assessments for proposed design changes in accordance to regulatory submission and engineering change notification process.
- Contribute to design input requirements from experience with previously reported problems from internal sources (non-conforming material reports, yield, rework) or external sources (customer complaints), competitive devices and/or other similar products
- Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
- Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Generate internal quality documentation such as quality plans, standard operating procedures and inspection procedures.
- Participate in Quality Review Boards. Identify non-conformance trends and develop technical investigation plans. Investigates and analyze customer/internal complaints.
- Monitor field quality and analyze field returns to determine root cause.
- Provide training and support for quality system processes and quality engineering practices
Requirements for the Quality Engineer:
- BS/BA in Engineering, life sciences, or similar.
- 5-8 years in medical device quality assurance; minimum 5 years in product development.
- Demonstrated working knowledge of 21 CFR 820, ISO 13485, ISO 14791, and other related medical device standards.
- Self-motivated and able to balance multiple priorities and tight deadlines with minimal supervision.
- Excellent communication skills -- verbal and written.
Compensation for the Quality Engineer:
- $85,000 - $90,000 based on relevant experience
- Comprehensive Benefits Package
Please send resumes to Mia Rogari at firstname.lastname@example.org
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Clinical & Life Sciences
King Of Prussia, PA 19406