Quality Assurance Manager

Job Description

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
  
  

Skills And 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)
• 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.
  
  

Company Description

Established in 1989, twenty-five years after Tosoh set up its first US office, Tosoh America, Inc. is today the parent company to the rapidly expanding number of Tosoh group companies within North America. In addition to integrating the corporate activities of its subsidiaries, this regional headquarters is working to expand Tosoh's business lines and operational capabilities within North America. Tosoh America is headquartered in Grove City, Ohio.

The Tosoh Group America companies, held under Tosoh America, are engaged in advanced technology fields ranging from the manufacture and sale of semiconductor and solar materials, to the sale of medical diagnostic instruments, high performance liquid chromatography (HPLC) and bio-separation media, and a wide range of other chemicals and advanced materials. These operations encompass manufacturing, distribution and sales, regulatory and technical support as well as equipment servicing, serving customers in the IT and high-tech, chemical, pharmaceutical and medical industries.

Established in 1989, twenty-five years after Tosoh set up its first US office, Tosoh America, Inc. is today the parent company to the rapidly expanding number of Tosoh group companies within North America. In addition to integrating the corporate activities of its subsidiaries, this regional headquarters is working to expand Tosoh's business lines and operational capabilities within North America. Tosoh America is headquartered in Grove City, Ohio. The Tosoh Group America companies, held under Tosoh America, are engaged in advanced technology fields ranging from the manufacture and sale of semiconductor and solar materials, to the sale of medical diagnostic instruments, high performance liquid chromatography (HPLC) and bio-separation media, and a wide range of other chemicals and advanced materials. These operations encompass manufacturing, distribution and sales, regulatory and technical support as well as equipment servicing, serving customers in the IT and high-tech, chemical, pharmaceutical and medical industries.