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1+ months

Sr QA / RA Specialist - European Product Development Office

Tolochenaz, VD
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Sr QA / RA Specialist - European Product Development Office


Tolochenaz, Vaud, Switzerland

Requisition #:


Post Date:

Sep 12, 2018

**Careers that Change Lives**

This position will be responsible for design quality and regulatory assurance activities and will participate in external and internal quality audits. Primary responsibility will be to handle quality engineering and regulatory assurance duties associated with new product development: design controls, quality planning, establishment of appropriate manufacturing process validations controls and regulatory submissions.

**A Day in the Life**

Design Quality Assurance (85%)

oParticipate in new product development projects by providing quality engineering services to assigned projects.Ensure defendable engineering and scientific analyses are employed and design history files comply with company policies and governmental regulations. Key deliverables including, but not limited to product performance analysis on similar products, risk analysis, failure mode and effects analysis, essential requirements checklist, design verification / validation, design transfer to manufacturing, documentation completion tracking, and product release authorization for distribution of product

oReview drawings to evaluate quality requirements including correct application of geometric dimensioning and tolerancing, proper use of engineering, process and material specifications, and identification of key characteristics for inspection plans and methods.Recommend revisions to assure design requirements are specified in the appropriate detail and clarity to provide a successful design transfer. Review and approve engineering change requests.Review product verification and validation plans and approve reports.Design Controls/Quality System

oConduct investigations to identify root cause of problems and implement effective corrective actions.Participate in internal audits and suppliers evaluations. Defines and establishes needed quality initiatives. Develop quality system procedures through cross-functional teams. Production and Process Controls

oUnderstand and apply the manufacturing quality toolset including PFMEA, IQ, OQ, PQ, GRR/measurement system analysis, control plans, process verification/validation plans, validation protocol development, Cpk, Cp, SPC, hard gaging applications, computer-based inspection methods, operator work instructions, DOE, process data analysis, and DMAIC

oAssist manufacturing sites with the interpretation of quality requirements including verification/validation planning and execution, first production run requirements, and problem resolution.Develop control plans that identify inspection characteristics, gauging techniques, and sampling requirements. Work with manufacturing sites to resolve conflicts and recommends revisions as required

Regulatory assurance (15%)

oCoordinates and prepares document packages for regulatory submissions for Product Development Europe activities

oSupports project needs for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.

oCompiles all materials required in submissions, license renewal and annual registrations.

oKeeps abreast of regulatory procedures and changes.

oMay direct interaction with regulatory agencies on defined matters.

oRecommends strategies for earliest possible approvals of clinical trials applications.

**Must Have: Minimum Requirements**

Proficient with Microsoft Office (Word, Excel, PowerPoint)

5 to 7 years of Experience in the medical device industry, ISO 13485, MDD 93/42 and other regulations that may apply

Experience in the application of production and process controls including process validation, process control plans and statistical process control.

Experience representing their department during quality system audits

Experience in product mechanical evaluation testing and GDT

Fluent in English

Ability to work effectively in a team environment and build strong working relationships.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.


Posted: 2018-09-14 Expires: 2018-11-22
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Sr QA / RA Specialist - European Product Development Office

Tolochenaz, VD

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