Quality Assurance Manager
Quality Assurance Manager
Tosoh Bioscience, Inc.
Columbus, Ohio Metropolitan Area
See who Tosoh Bioscience, Inc. has hired for this role
Quality Assurance Manager
Major Duties and Responsibilities
- Demonstrates an understanding of the regulatory and Company requirements and to perform gap assessments to those requirements.
- Manage and or support internal audits, supplier audits, NC/CAPA, quality agreements.
- Support Third Party Audits for FDA, and MDSAP as backroom coordinator and Subject Matter Expert.
- Review, establish, maintain, and report, monthly and quarterly, Quality metrics for the organization and QMS system.
- Perform investigations analysis independently including gap assessments and root cause analysis evaluations to determine risk level utilizing root cause analysis tools.
- Uses technical, scientific, and professional judgment for assessing the effectiveness of CAPAs and communicates to supervisor and area management when deficiencies are found.
- Ensures that CAPA, non-conformance, and supplier records are accurate , complete, and contain correct references to Quality documents, and or processes such as Change Management, Audits, Non-Conformances, and Complaints.
- Critical Review of documents and document change requests. Experience in assessing the weight of evidence associated with a claim/hypothesis/ assertion is preferred.
- Ensures the best level of service in compliance with reference rules and standards
- Ensuring the level of scientific and technical skills necessary for the performance of your tasks
- Contributes to business development and image/branding of the company.
- Other duties as assigned, according to the changing needs of the business
Qualifications:
- Bachelor’s degree in industrial technology, Biology, Chemistry, Biochemistry, Electrical/Electronic/Mechanical or Bioengineering.
- Minimum 8 years’ experience in the field of medical devices and healthcare products or related medical device manufacturing, auditing, or Quality Assurance.
- Full time hands-on direct work experience can be in one or more of the following: (manufacturing, Quality Systems implementation/maintenance, compliance with relevant national or international standards; performance testing, evaluation studies or clinical trials of the devices)
- Leadership and managing direct reports experience required.
- Proficiency in Office Applications required.
- SmartSolve software or equivalent Quality Management system experience required.
- Understanding of quality concepts such as: cost of quality, analytical metrics, statistics and trending, quality planning, validation, CAPA and problem solving
- Management of third party audits/inspections, internal audits, supplier audits, document control, change control, training, NC/CAPA, quality agreements, training employees.
- HIPPA Compliance
- Experience creating employee development plans.
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Seniority level
Associate -
Employment type
Full-time -
Job function
Quality Assurance, Engineering, and Manufacturing -
Industries
Medical Equipment Manufacturing, Machinery Manufacturing, and Manufacturing
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