The Quality Systems Specialist will participate in the management, governance, and execution of Quality Management sub-systems. Specifically, this 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 Documentation Control. Additionally, this role will support specific quality improvement projects as required for 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
- Support the POC Document Control processes within the Edgewater location.
- Support the Internal and External Audit processes by participating as an internal auditor and participating in external 3rd party audit processes.
- Support the development, monitoring and reporting of Quality Systems key performance indicators (KPIs).
Required Knowledge/Skills, Education, and Experience
1-3 years of experience in a Quality role within an FDA regulated industry preferably medical device and diagnostics that includes experience with document control, training, 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 disciplines in English, technical writing, or similar. 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
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