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Quality Assurance Manager
4 months ago
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.
+ Will oversee a team of 5 people to start.
QUALIFICATIONS:
+ Education: Bachelors 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.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
+ Hiring diverse talent
+ Maintaining an inclusive environment through persistent self-reflection
+ Building a culture of care, engagement, and recognition with clear outcomes
+ Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
