Quality Assurance Principal Engineer

Job Description

A quality assurance principal engineer is responsible for the Quality Assurance, Quality Control, and Quality Systems in the medical device industry. We are looking for an experienced quality assurance principal engineer who can lead the design assurance and risk management team and ensure system quality and compliance.

Duties and Responsibilities

• Lead the quality and risk management process, including design assurance, CAPA, and supplier management.
• Fully responsible for ensuring that all design control activities are regulated and meet FDA/EU expectations.
• Review and approve design controls and product documentation.
• Provide guidance or supervision for qualified personnel with less experience to perform design verification and validation or other quality assurance activities.
• Ensure product safety by driving risk management activities.
• Provide guidance on the selection of statistical analysis and sample size for design verification and validation and other identification and acceptance testing.
• Sign quality agreements with contract manufacturers.
• Plan and execute internal or external audits in accordance with applicable quality system standards, regulations, and requirements.
• Support the development of safe and effective medical devices that comply with international regulations.
• Ensure the integrity of design history files.
• Ensure effective transfer of design to contract manufacturing partners and operations.
• Support and facilitate successful completion of risk management activities for new product development projects.

Qualifications

• Master's degree (M.S./M.A.) or Ph.D. in Engineering.
• Have a strong statistical background and experience in Minitab, JMP, or similar statistical software packages.
• Be able to apply the knowledge required by the FDA QSRs, ISO 13485, and ISO 14971 to a wide range of processes and issues.

Locations

Shirley, NY

Job Type

Full-time

Job Family

Quality Management

Job ID

#496551