Sr Quality Assurance Engineer
Insulet Corporation View all jobs
- China
- Permanent
- Full-time
The Senior Quality Engineer is responsible for ensuring new and existing products conform to the Insulet Quality System, Quality System Regulation, ISO 13485 and ISO14971. He/she is responsible for maintaining a strong collaborative partnership with cross-functional team members. He/she will serve as a Quality representative to improve awareness, visibility, and communication on all quality initiatives in order to support departmental, functional and corporate quality goals and priorities. He/she can effectively communicate with all levels of the organization.Responsibilities:
- Ensures new product introduction quality deliverables are created and properly executed (e.g. Project Quality Plan and Risk Management Plan).
- Works with teams to establish measurable, valid product requirements.
- Supports Risk Management activities from product Concept through Commercialization.
- Supports DHF content completion, integrity, and regulatory and standards compliance. Identifies gaps, collaboratively communicates and works with team to resolve gaps.
- Review and approve design control documentation (e.g. plans, protocols, reports) ensuring compliance with the Insulet Quality System, Quality System Regulation, ISO 13485 and ISO14971.
- Provide guidance as needed to assure country specific compliance to the laws and regulations of the targeted market for distribution.
- Supports manufacturing process development & qualification for new product commercialization and product changes.
- Provides project direction, coaching, and mentoring for engineering and technical team personnel.
- Apply sound, systematic problem solving methodologies identifying, prioritizing, communicating and driving resolution of quality issues.
- Performs other duties as required.
- BS degree in engineering, a technical or scientific discipline; and/or equivalent combination of education and experience.
- Master’s degree in engineering or technical or scientific discipline preferred.
- 5-7 years’ experience in the FDA regulated environment.
- Experience in Quality in an FDA regulated industry.
- Experience with QSR Part 820, ISO 13485 and ISO 14971.
- Experience with ETO sterilization methods preferred.
- Experience with methods and standards for the design, verification, and validation of medical device products.
- Experience with statistical methods (e.g. statistical process control, sampling plans, gauge R&R, and design of experiments).
- Experience with word processing, spreadsheet, database programs.
- Effective verbal and written communication skills.
- Effective collaboration and communication with individuals at multiple levels in an organization.
- Ability to organize and judge priorities.
- Ability to generate and maintain accurate records.
- Ability to follow up with task owners to close out open items.
- Strong problem solving / root cause analysis skills.
- Good verbal (including presentation) and written communication skills, especially technical report writing.
- Ability to generate and maintain organized and accurate records.