Quality Engineering Manager Molecular Diagnostics
Business Unit: Strategy & Innovation
Requisition Number: 231028
Primary Location: United States-California-Berkeley
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 20%
At Siemens Healthineers, we are passionate about enabling healthcare professionals to deliver high quality patient care, and to do so affordably. A leading global healthcare company, Siemens Healthineers continues to strengthen our portfolio of medical imaging and laboratory diagnostics, while adding new offerings such as managed services, consulting, and healthcare IT services – as well as further technologies in the growing market for therapeutic and molecular diagnostics.
Siemens Healthineers develops innovations that support better patient outcomes with greater efficiencies, giving providers the confidence they need to meet the clinical, operational and financial challenges of a changing healthcare landscape.
The open position is for a Quality Engineer Manager within the Quality Management team for Molecular products. The successful candidate will be responsible for representing quality in maintaining design and process controls in an R&D facility. The manager will be responsible for providing quality expertise as well as creating, reviewing, and approving documentation to ensure compliance with internal procedures and regulatory requirements for in-vitro diagnostics. Applicable topics or deliverables include design controls, equipment maintenance, environmental deviations, product and process nonconformance’s, process validations, design and manufacturing process risk management, process changes, packaging/shipping validation, design transfer, Supplier qualification, Supplier Corrective Actions, technical reports, deviations, CAPAs, and quality plans. In addition, the candidate will support and participate in both internal and external audits. This role reports to the Director of Quality, located at our Siemens Molecular Diagnostics headquarters based in Berkeley, CA.
Qualifications - Education & Experience
· Bachelor’s degree in an engineering or scientific discipline or equivalent experience
· Minimum six (6) years quality and/or regulatory experience in a R&D or production environment at a medical device manufacturer
· Minimum three (3) years design quality assurance / design quality engineering experience
· Experience leading multi-disciplinary design and/or manufacturing teams
· Knowledge of applicable US (21 CFR 820) and EU (ISO 13485:2016) quality system requirements
· Driven individual with a history of developing collaborative, cross-functional solutions in an international setting
· Highly developed writing and interpersonal skills with the ability to work on diverse teams located at different geographical locations
· Working knowledge of common computer software applications (WORD, EXCEL, Adobe Acrobat, etc)
· Experience leading audits per ISO 13485 and/or FDA QSIT methodology preferred
· Working knowledge of Risk Management (ISO 14971:2012) or Medical Device Software (IEC 62304) standards preferred
· Prior supplier quality experience (Supplier Audits, SCARS) a plus
Qualifications - Skills & Competencies
· Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.
· Proven record in problem solving and implementation and management of a quality system such as ISO 9001/TL9000, ISO 13485, and FDA IVD requirements for design and development and manufacturing processes.
· Strong familiarity with Design Controls, Design Transfer, Design and Process Validation requirements, Risk Management, and related QSR and international regulatory requirements.
· Ability to lead and coordinate quality system audits - both internal and external.
· Excellent interpersonal skills and ability to develop relationships with key stakeholders; problem solving, risk analysis and negotiation skills
· Ability to communicate issues in a simple way and to orchestrate plans to resolve issues and risks.
· Effective leadership, organization, communication, and team-centric orientation skills
· Ability to motivate and influence people to achieve compliance to requirements
· Prior experience in building and leading teams preferred
· Prior experience with electronic Quality Management Systems (eQMS) preferred#LI-AW1