Quality Engineer (Medical Device-Spine)

The Position
Quality Engineer (Medical Device-Spine)
Medical Equipment / Devices
Information Technology - Quality Assurance

Full-time
United States - California - San Diego - Vista
The Compensation $ 80,000 -$91,000
Benefits - Full

Relocation Assistance Available - No

Commission Compensation - No
Bonus Eligible - Yes
Overtime Eligible - No
Interview Travel Reimbursed - No

Detailed Description

The Quality Engineer's responsibilities include assisting with the development of quality systems, procedures and controls to ensure that products consistently meet performance and quality specifications. The Quality Engineer is a leader and strong technical resource who quickly, effectively and permanently resolves quality problems with internal and external customers and suppliers.

Primary responsibilities are to:

Take a leadership role on customer complaints to identify, coordinate and effectively resolve problems in a timely manner and maintain GMP and ISO 13485 compliance

Responsible for complaint evaluations, analysis, trending and reporting of complaint data using standard statistical techniques and complaint processing and presentation software

Assist with providing a strong quality direction in new product development and design change efforts to ensure that products meet performance/quality specifications and are highly manufacturable

Assist with the development of critical-to-quality specifications, test plans, protocols, procedures, tools, meaningful metrics and controls for all aspects of manufacturing, packaging, cleaning, sterilization, inspection and shipping

Assist with the development of plans and oversee the qualification of new suppliers and raw materials domestically and internationally

Work to quickly and permanently resolve supplier quality issues

Establish procedures for statistical methods (DOE, sampling, and ANOVA)

Specify and design inspection, test methods, fixtures, and set-ups for the Quality Control Department and vendors

Develop and implement policies, procedures and work instructions for the Quality Control Department

Manage equipment, preventative maintenance, and instrument calibration process and documentation

More About the Position
40+ Hours per Week

Visa Candidates Considered - No

The Candidate
2+ to 5 years of experience
Management Experience Required - No
Minimum Education - Bachelor's Degree

Willingness to Travel - Occasionally

The Ideal Candidate

The ideal candidate has worked for these companies:

Medtronic, DePuy, Synthes, Stryker, Nuvasive, Zimmer