17 days old

Strategy & Innovation Quality Manager

Mountain View, CA
**Strategy & Innovation Quality Manager**

Locations:Mountain View, California

Job Family: Quality Management


English (US)

**Job Description**

**Division:** Siemens Healthineers

**Business Unit:** Services

**Requisition Number:** 218355

**Primary Location:** United States-California-Mountain View

**Assignment Category:** Full-time regular

**Experience Level:** Mid level

**Education Required Level:** Bachelor's Degree

**Travel Required:** 15%

**Division Description:**


**Job Description:**

Siemens Healthineers is looking for talented individuals destined to usher in the next era of healthcare. We live in a moment of remarkable change and opportunity. The convergence of data and technology is transforming healthcare and our business in every way. The successful candidate for the level Quality Manager position will be responsible for driving quality policies, processes and procedures within a digital innovation team. The successful candidate 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 software non-medical/medical device solutions. In addition, the successful candidate will support the onboarding of new suppliers and participate in both internal and supplier audits.


Lead Quality Management in Digital Health Innovation and Incubation Space for Services team

Provides quality compliance guidance throughout new digital product development, product changes and other key internal projects

Leverages experience with quality system elements to develop and implement process improvements

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

Guides and/or mediates the decision making process on project and deliverable execution

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

Participates in audits and inspections by regulatory authorities and certification/accreditation bodies.

Required Knowledge/Skills, Education, and Experience

Minimum BA/BS in scientific discipline

Experience mapping software development processes to meet regulatory requirements while using agile methodologies.

Experience in implementing HIPAA compliant Cloud Solution

Has knowledge and or experience with regulations and standards (i.e QSR, ISO, Canadian etc).

Experience managing Quality management system elements such as CAPA, internal audit, document management, etc.

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

Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.

10% travel required

Preferred Knowledge/Skills, Education, and Experience

New product core team experience preferred

Possesses regulatory affairs knowledge and understanding of global regulatory systems, processes, polices and requirements preferred

Demonstrates a good grasp of lean principles that can be applied through successful completion of assignments. Value stream mapping experience a plus.


**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 at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm .

**Pay Transparency Non-Discrimination Provision**

Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here at https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf .


  • Legal
  • Healthcare

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Mountain View, CA

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