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Quality Director
Planet Innovation - Irvine, CA
posted about 2 months ago
About the position
The Quality Director at Planet Innovation is responsible for leading quality assurance efforts within the US manufacturing site. This role involves ensuring compliance with various quality standards, mentoring the quality team, and collaborating with engineering teams to uphold product quality and regulatory compliance. The position reports to the Vice President of Quality Assurance/Regulatory Affairs and plays a critical role in maintaining the integrity of the Quality Management System (QMS).
Responsibilities
- Act as a subject matter expert and provide guidance on quality system elements to ensure compliance.
- Assist VP QA/RA in reporting to top management on QMS performance and improvement needs.
- Mentor and develop the US Quality Team.
- Lead the Quality Team to support ongoing global regulatory compliance including submissions.
- Conduct quality planning within supporting US business units.
- Ensure all project/program work products meet quality, reliability, and compliance requirements.
- Collaborate with engineers in the development and design review of protocols and data summaries.
- Conduct QA activities including audits, reviews of records, and quality awareness training.
- Participate in hazards and risk analysis studies of design and processes.
- Utilize risk management principles to identify critical quality attributes.
- Compile and analyze complaints, performance reports, and process control statistics.
- Develop quality assurance programs to achieve reliability objectives.
- Ensure Design Requirements Flow and Design for Reliability and Manufacturability are applied.
Requirements
- 6+ years in a Senior Medical Device QA role or at least 3 years in a managerial position within a contract manufacturing environment.
- Experience complying with international quality standards such as ISO 13485, ISO 9001, and FDA QSR regulations.
- Degree in Science or Engineering.
- Working knowledge of ISO 14971, IEC 60601/61010, and IEC 62304.
Benefits
- 401(k) matching
- Dental insurance
- Health insurance
- Paid holidays
- Vision insurance
