Siemens Careers

Senior Quality Engineer Molecular Diagnostics

Berkeley, California
Quality Management

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English (US)

Job Description

Division: Siemens Healthineers
Business Unit: Strategy & Innovation
Requisition Number: 233417
Primary Location: United States-California-Berkeley
Assignment Category: Full-time regular
Experience Level: Senior level
Education Required Level: Bachelor's Degree
Travel Required: 10%

Division Description:

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.



Job Description:

Position overview

The open position is for a level 4 Quality Engineer within the Quality team for Molecular Diagnostics, located in Berkeley, CA. The successful candidate will be responsible for representing quality in product development projects and change management activities. The position is 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 and medical devices. Applicable topics or deliverables include design control deliverables, design transfer, process validations, product risk management, design / process change control, supplier management, technical protocols & reports, packaging / labeling / shipping protocols & reports , complaint investigations, nonconformance, CAPAs, deviations and quality plans. This position reports to the Manager of Quality Engineering within the business line. Must be able to work independently, interface effectively, and demonstrate a high level of reliability, integrity, and personal accountability, as a member of the Siemens quality management team. 

Responsibilities

• Represents quality on project core teams and/or change teams to ensure that process execution and documentation meet quality and regulatory needs

• Facilitate cross-functional discussion on requirements definition, test planning, and design reviews to ensure development and manufacturing objectives are defined and met

• Leads discussions on product risk management (eg. hazard, hazardous situations, harms, mitigations, and objective evidence) to ensure products are safe and effective

• Be a leader in working with other quality engineers, functions, and sites to ensure that projects are delivered “on-time and on-quality”

• Provide proactive input on project strategies and process tailoring to minimize project risk

• Works with external partners to ensure suppliers and products are appropriately qualified with strong quality interfaces in place

• Communicates quality goals and issues with technical and supporting team members, as well as management

• Leads initiatives to improve processes to achieve gains in compliance and efficiency
• Assists with the decision making process on project and deliverable execution

• Applies knowledge and promotes learning of internal procedures
• Interacts with and coordinates with employees in a global company to support business unit objectives
• Reviews and approves documentation for compliance with US, EU, and other international regulations
• Identifies and manages areas of potential noncompliance

Required Knowledge/Skills, Education, and Experience

• Minimum BA/BS in scientific discipline
• 7+ years’ experience in a quality engineer at a IVD or MD manufacturer
• Knowledge of applicable US (21 CFR 820) and EU (ISO 13485) quality system requirements with a focus in Design Controls

• Working knowledge of Risk Management for medical devices (ISO 14971)

• Prior experience in a quality role supporting new product development and design changes
• Driven individual with a history of developing collaborative, cross-functional solutions
• Highly developed writing and interpersonal skills with the ability to work on diverse teams located at different geographical locations
• 10% travel required
• Working knowledge of common computer software applications (SharePoint, SAP, WORD, EXCEL, Adobe Acrobat, etc)

Preferred Knowledge/Skills, Education, and Experience

• BS degree in Engineering, Molecular Biology or Biochemistry preferred
• 9+ years’ experience in a design quality engineering AND/OR manufacturing quality engineering role at a IVD  or MD Manufacturer
• Experience leading product development projects, design transfers, process validations, or CAPAs highly preferred
• Prior experience in in-vitro diagnostics highly preferred
• Lead Auditor experience per ISO 13485 and/or FDA QSIT audits preferred

• Certified Quality Engineer or Six Sigma Green Belt preferred



Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.

EEO is the Law
Applicants and employees are protected under Federal law from discrimination. To learn more, Click here.

Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.



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