Athens Categories:
Manager, Quality Assurance Diagnostic Hybrids
Category: Quality AssuranceDescription:
The Manager, QA has the primary responsibility for managing the quality assurance function, which includes the internal audit system, third party audits, training management system, risk management program, document control system and managing the QA department employees. The Manager, QA actively supports corporate strategic goals and objectives through oversight of the various Quality Assurance systems.
Develops, manages, and maintains an effective Internal Audit, CAPA, and complaint trending analysis process
Develops, manages, and maintains Risk Management System in support of development and manufacturing processes
Develops, manages, and maintains Training Management System through Master Control software and corporate training programs (e.g. ISO/QSR)
Implements and maintains overall compliance of the Quality Assurance system in alignment with Quidel Corporate processes and FDA/ISO/IVD/CMDR/USDA medical device regulations
Develops employees
Requirements:
BS/BA degree preferably in a Biological Science field or equivalent work experience
3-5 years progressively responsible experience in quality system management in medical device environment
Knowledge and work experience with Document Control Systems required
Knowledge and work experience with Master Control software preferred
Previous supervisory experience required
ASQ Certification (CQE, CQA and/or CQM) preferred
Knowledge of quality systems in a medical device manufacturing environment (ISO, CMDR, QSR, IVDD, and other worldwide regulations as appropriate)
Ability to work cohesively with multi-disciplinary working groups
Excellent written and verbal interpersonal skills to influence many diverse internal and external customer groups
Ability to influence and work with personnel at all levels
Managerial skills ? employee and team development / career development
Computer skills ? proficient in Microsoft Office, operating systems, and email, etc.
Project management, multiple tasking and excellent prioritization skills
Ability to work within office, laboratory, and manufacturing environments
Quidel is proud to be an Affirmative Action/Equal Opportunity Employer (M/F/D/V).
Location Athens , OH
Minimum Experience (yrs): 3
Required Education: Bachelors of Arts / Science
Benefits:
| Location: | Athens, OH 00000 United States |
|---|
Diagnostic Hybrids
Investors: Summit PartnersAll Jobs: at Diagnostic Hybrids
| Web Site: | www.dhiusa.com |
|---|---|
| Headquarters: | Athens, OH 00000 United States |
| Industry: | Other |
Support Diagnostic Hybrids with Social Media services
Find more Manager, Quality Assurance jobs
