QUALITY ENGINEER

We are looking for a strong leader who is results oriented and has the knowledge and confidence in the areas of Quality Assurance and Regulatory Assurance. Reporting to the Director of QA/RA you will act as a strong counterpoint in the department for keeping things moving until completion and final approval. This individual must work well with others and be very detail oriented with a savvy and well rounded knowledge of the medical device industry.

For over 30 years, Quantimetrix has been developing and manufacturing innovative clinical laboratory quality control products with the customer in mind. Each Quantimetrix employee is empowered to improve our processes through their exceptional work. We are currently recruiting for full-time Quality Validation/Process Engineer.

MAJOR DUTIES AND RESPONSIBILITIES:

- Provides focused hands-on validation & quality engineering support to R&D, Manufacturing and Quality Control. Continually seeks to drive improvements in product and process quality.

- Conducts FMEA, raw material characterization, risk management and equipment method validations.

- Utilizes standard statistical analysis and problem solving techniques to determine product acceptance, evaluate process capabilities and assist R&D in Design Control and process transfer to Manufacturing.

- Participates in design reviews for new product development and design/process changes.

- Acts as the CAPA coordinator, managing CAPAs from initiation to closure; maintains a chronological history throughout the process.

- Prepares & Reviews Validation protocols and final reports (IQ, OQ, PQ).

- Prepares SOPs and inspection/test methods and other change control related documentation.

- Prepares Master Validation Plans and participates in process qualifications.

- Responsible for ensuring all quality standards and specification are defined and achieved in line with appropriate regulatory requirements, especially the FDA Quality System Regulation and ISO 13485:2003.

- Prepare supplier corrective actions and supplier qualifications, as well as material change qualifications

- Fully participates in and successfully contributes to project teams typically including the following activities: product design and development, test of materials, preparation of specifications, process capability studies, research investigations, report preparation, and process/test documentation.

- Perform other tasks and duties as directed by the Director of Quality Assurance and Regulatory Affairs.

- Assist in maintaining Quantimetrix Corporation quality system.

QUALIFICATIONS:

Education: B.S. in related fields or equivalent, science or Engineering preferred. Minimum of 5+ years experience as a Quality engineer in a medical device / in vitro diagnostic manufacturing environment, with a minimum of 1 year as a lead or senior quality engineer. Validation experience required (IQ,OQ,PQ), writing validation protocols and reports. Strong knowledge and hands-on experience in the application and implementation of (GMP/QSR/ISO/MDD). In return for your hard work and dedication, we offer a competitive compensation and benefits package that includes medical, vision, dental, life insurance, matching 401(k) plan, PTO and other great benefits.

For more information about us, please visit our website: Quantimetrix. If interested, please send your resume with salary history to Human Resources or fax to (310) 347-4031. EOE