Senior Quality Engineer II - Design Control & Compliance

Werfen; Bedford (MA); Sur place; USD 150 000 - 180 000; Plein temps

Avantages offerts par ce poste

Medical, dental, and vision insurance

401k with employer match

Paid vacation and sick leave

Résumé du poste

Werfen is seeking a senior quality/regulatory professional to oversee product lifecycle compliance, lead design control and product realization for in vitro diagnostics products, and drive CAPA actions across Manufacturing, R&D, and Distribution. This role emphasizes strong regulatory knowledge, risk assessment, and the application of statistical methods to ensure compliant, high-quality IL products.

The ideal candidate has 10+ years in medical devices or diagnostics, a Bachelor's in engineering

Qualifications

• Education: Bachelor's degree or equivalent in engineering or science
• Experience: A minimum of 10 years of experience in medical devices, pharmaceuticals, diagnostic industry, or clinical laboratory or 7 years of experience with an advanced degree.
• ASQ Quality Engineering Certification - Desirable
• LEAN/Six Sigma Certification - Desirable
• Language: English

Responsabilités

• Participates in the generation and review of quality documents throughout the product lifecycle
• Advises and directs teams regarding compliance to procedures, standards and regulations
• Ensures product quality meets requirements and documentation is complete prior to approval
• Leads Design Control and Product Realization for IL products on significant projects
• Reviews change orders for product performance, process changes, labeling and marketing communications as required

Connaissances

Regulatory knowledge

Quality management

Risk management

Statistical methods

Formation

Bachelor's degree or equivalent in engineering or science

ASQ Quality Engineering Certification - Desirable

LEAN/Six Sigma Certification - Desirable

Description du poste

Werfen is seeking a senior quality/regulatory professional to oversee product lifecycle compliance, lead design control and product realization for in vitro diagnostics products, and drive CAPA actions across Manufacturing, R&D, and Distribution. This role emphasizes strong regulatory knowledge, risk assessment, and the application of statistical methods to ensure compliant, high-quality IL products.

The ideal candidate has 10+ years in medical devices or diagnostics, a Bachelor's in engineering