QA Engineer

Medtronic. Careers with a passion for life.As the world’s leading medical technology company, we provide lifelong solutions to people with chronic disease. Everything we do is deeply rooted in our mission—to alleviate pain, restore health, and extend life. Every 5 seconds the life of someone somewhere in the world is improved by a Medtronic product or therapy. We also are dedicated to the total well-being of our employees and have been recognized for seven of the last nine years by Fortune magazine as one of the "100 Best Companies to Work For in America." Work with the kind of people who not only love what they do but why they do it.
QA Engineer
Santa Rosa, CaliforniaThe QA Engineer provides technical QA support and recommendations for process / system improvements concentrating on Medtronic product manufacturing, research and development, and the quality department activities. The QA Engineer also provides applicable regulatory compliance support for the implementation of a GMP/ISOs quality system.
Responsibilities: Provide quality engineering online support to manufacturing operations.
· Support manufacturing process controls, SPC and report periodic manufacturing yield/scrap.
· Trouble shooting online quality issues like non-conforming material, inspection etc.
· Provide technical support to Receiving Inspection, Regulatory Affairs and the Testing Lab.
· Develop and document statistically sound sampling plans.
· Develop an understanding of the product, the procedures the customer follow, the terminology associated with the product use and the failure modes typically experienced by the customer.
· Evaluate, procure and install the required equipment to measure and evaluate product performance.
· Develop systems to transfer products from R&D to manufacturing in an expedient manner assuring finished product quality and safety.
· Develop a corrective action loop to include raw materials, work in process, finished product and customer evaluation.
· Develop a system to monitor and maintain the Controlled Environment Rooms for particulate and bioburden levels.
· Perform validations to implement new tests and/or test equipment.
· Perform process validation / process characterization for process improvements.
· Communicate within Medtronic and with other Medtronic facilities regarding any quality-related problems, ensure closure of the problem and remedial and corrective actions are implemented.
· Document and train the QA Supervisor and technicians to follow the appropriate laboratory product inspection procedures.
· Continually update and make improvements to the test methods, inspection forms and related documentation used to evaluate product functionality and quality.
· Identify and provide possible solutions for any issues that prevent the release of product to the field or to other Medtronic facilities.
· Develop and implement systems to achieve FDA facility registration and ISO certification/CE marking.
· Develop systems to assure product specification conformance.
· Develop a product complaint system and evaluate product returns and write summary reports.
· Develop and maintain a calibration system.
· Hire, train and review QA manufacturing support staffing.· Coordinate first article testing required for new materials and components.
· Inputs operating budget and space management proposals.
· Other duties as defined.
· Good prioritization and verbal/written skills
· Able to accomplish multiple assignments simultaneously
· Good working relationship with peers
REQUIREMENTS
Requirements: BS in a Life Science or Engineering
· Extensive GMP training
· 3 years experience in QC/Medical Device manufacturing preferred
· Experience with Microsoft PC applications preferred
Lifting/Carrying 10 - 30 lbs. Or more 0.5 hrs/day
Bend/Stoop/Knee 4 hrs/day
Push/Pull 50 lbs. 0.5 hrs/day
Stand/Sit/Walk 8+ hrs/day
We are currently seeking multiple individuals for Engineering opportunities throughout Medtronic. Qualified candidates with all levels of experience are encouraged to submit an application in consideration for this or similar opportunities. This opportunity is based in Santa Rosa, California. Other opportunities may also exist at our locations in Minneapolis, Minnesota; Northridge, California; Redmond, Washington; Denver (Louisville), Colorado; Ft. Worth, Texas; Memphis, Tennessee; Danvers, Massachusetts; and Jacksonville, Florida.
With people like you who have purpose, potential and passion, we’ll supply physicians and their patients around the world with the means to alleviate pain, restore health and extend life.TO APPLY: Please submit your resume at www.medtronic.com/employment. Review Regulatory Affairs openings or enter Requisition # 52335 and select "Add to Cart" or "Apply to this Job" to route your resume directly to the hiring department. No agencies or phone calls, please.Medtronic is an equal opportunity employer committed to cultural diversity in the workforce.