Manager, Design Assurance

Position: Manager, Design Assurance

Job Description:

Support site quality and R&D teams by addressing emergent issues that might arise due to the design and development processes. Participate in Design Project Teams as a Quality Representative to ensure that input requirements (internal, external, and customer) are clearly defined, risk assessment is performed, output meets input requirements, and objective evidence supports conclusions.

Additionally, ensure that quality related issues are adequately addressed. Perform quality related design control activities as assigned by Design Project Team. Partner with production during Design Transfer phase to ensure that products and processes meet all quality requirements.

Manage the risk management process and associated documentation, ensuring that product FMEAs, Hazard assessments, etc. are regularly updated as procedurally required. Interface with external agencies (Notified Body, FDA, etc.) during audits/inspections, representing design control. Provide guidance and leadership on design process characterization studies (DOE, R&R); conduct statistical analysis of results to identify critical parameters and improve process capability.

Provide expertise and guidance on industry standards related to ophthalmic devices, and ensure company procedures and practices are consistent with these standards. Interface with Complaint Handling team to identify post market surveillance data trends and feed that back to R&D to support current or future development projects. Coordinate quality engineering activities to achieve business objectives. Train, mentor, and develop staff.

Requirements:

Master's degree in Biomedical Engineering, Biotechnology, or in a related field

Two (2) years of experience in job offered, or as a Quality Engineer, or Supervisor, Design Assurance, or in a related occupation

Experience must include in an FDA regulated environment, with quality engineering experience; familiarity with the practical application of FDA CFR 820 Quality System Regulation, ISO 13485 Quality System standard and ISO 14971 Risk Management standard; knowledge of ISO standards related to the design, manufacture, and clinical use of ophthalmic devices; and design control experience.

Job site: Monrovia, California.

Telecommuting is an optional benefit of the employment. Employee may live anywhere in the U.S.

Salary range - $100,000 - $140,000 per year - Final compensation/salary will depend on experience.

STAAR Surgical is an Equal Opportunity/Affirmative Action employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran or disability status, or any other characteristic protected by law.