The Quality Systems Project Manager will participate in the management, governance, and execution of Quality Management sub-systems. Specifically, the person will be required to interact and collaborate with cross functional teams to promote and drive Quality Systems compliance regarding training, internal/external auditing, and CAPA. Additionally, this role will lead specific quality improvement projects as required to support QT and other business initiatives. The individual filling this role is expected to apply problem solving and interpersonal skills and be able to influence and drive results.
Major Job Responsibilities
- Manage the POC CAPA program within the Edgewater location.
- Manage the Internal and External Audit processes, which will include the harmonization of these process across POC.
- Support the development, monitoring and reporting of Quality Systems key performance indicators (KPIs), which will include assisting in the development of Quality Goals & Objectives across POC.
Required Knowledge/Skills, Education, and Experience
5 – 8 years of experience in a Quality role within an FDA regulated industry preferably medical device and diagnostics that includes experience with CAPA and auditing processes. ASQ certifications such as CQA, Six Sigma, CQE, CQT or equivalent are highly desirable.
Job Family Responsibilities:
Analyze complex production and quality trend data to identify and solve problems. Designs and develops systems for recording, evaluating, and reporting quality data. Perform economic implication analyses, prepares reports of findings and carries out complicated implementation and training assignments. Conducts complex audits and/or surveys to determine acceptability of quality controls
Typically AS degree in a related discipline or equivalent combination of education and experience. Prefer discipline in Engineering, Biochemistry or Chemistry or other technical field. Prefer candidates that possess internal auditor certification (CQA) from ASQ or equivalent training in IVD / biomedical industry.
Knowledge and Experience:
Demonstrates and applies a broad knowledge of field of specialization through successful completion of moderately complex assignments. Successfully applies complex knowledge of fundamental concepts, practices, and procedures of particular area of specialization. Demonstrates knowledge of organization's business practices and issues.
Direction of Others: N/A
Key Working Relationships: Primarily intra-organizational contacts and external contacts.
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Mid-level Professional
Job Type: Full-time
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 unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, 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.
California Privacy Notice
California residents have the right to receive additional notices about their personal information. To learn more, click here.