Quality Assurance Manager

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.