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Manager, Design Quality Engineering (FDA)

Company: Kforce Inc.
Location: San Clemente
Posted on: September 4, 2019

Job Description:

RESPONSIBILITIES:Kforce has a client in search of a Manager, Design Quality Engineering (FDA).SummaryThe Manager, Design Quality Engineering ensures product development and utilizes appropriate engineering and scientific analyses during the product development and commercialization. They will work directly with Quality Engineers to provide guidance and direction relating to pipeline and on-market product development teams. This individual will be responsible for implementation and maintenance of the companies Quality System/Medical Device standards to ensure compliant, safe and effective products. They will manage new product offerings and product life cycle management by assuring adequate completion of Qualification activities, compliance companies Quality System and overall strong product documentation records.Essential Duties & Responsibilities: Provide effective tactical Quality leadership for Quality Engineers and direct reports Supervise employee's and help them to establish the Quality goals and requirements for programs Interact and communicate with Senior Leadership across the firm regarding program status, risks, mitigation plans and business objectives Effectively deploy and assure compliance with the Quality System such as design controls, risk analysis/management tools, design validation, design verification, investigations, CA/PA data, etc. to assure product quality Support manufacturing site inspections/audits, representing and defending product quality across design controls, risk analysis/management tools, design validations, design verifications, investigations, CA/PA data, etc.; Interact directly with regulatory agencies during audits including Notified Bodies and FDA Assure site systems conform to all applicable company standards, US, and international regulatory requirements and coordinate development of data and responses to regulators Understand Medical Device regulations and assure the Medical Quality SystemsREQUIREMENTS: Bachelor's degree from an accredited institution in Engineering, Engineering Management or a related Science field is required, along with formal training in Quality Engineering MBA or Master is preferred, but not required Six Sigma Black Belt, ASQ, CQE, and/or CQM certifications highly desirable Minimum experience 5 years; 10 years preferred Required experience of 3-5+ years of quality management in FDA consumables in a design focused, R/D environment Demonstrated ability to lead, direct and influence others Excellent knowledge of the philosophy and principles of quality engineering and quality management Demonstrated problem solving and decision-making skills Strong understanding of failure analysis, test method validation and engineering tolerances Broad knowledge of manufacturing operations and quality system practices Strong verbal, written and interpersonal listening skills with track record of successful project management Demonstrated regulatory audit facing experience Excellent knowledge of Minitab or other statistical software, MS Word, Excel and MS ProjectKforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Keywords: Kforce Inc., San Clemente , Manager, Design Quality Engineering (FDA), Other , San Clemente, California

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