Quality Assurance Manager
LocationNorth Charleston, SC
Job TitleQuality Assurance Manager
Employment TypeDirect Placement
Quality Assurance Manager
Expand your professional portfolio as a Quality Assurance Manager with our client in North Charleston, SC. As the Quality Assurance Manager, you will be responsible for the day to day management of the Quality Assurance processes for instrument calibration and preventative maintenance, document control, training, RMA, and CAPA/NCR administration. This is a direct-hire opportunity.
- Competitive pay
- Direct-hire opportunity
- Bachelor’s degree (science or engineering major).
- Appropriate college level classes (preferred)
- Experience in QA or manufacturing field can substitute for degree
- 3+ years of experience in device or pharmaceutical or biotechnology QA or manufacturing
- Knowledge of quality principles applicable to medical device products, including FDA, QSR, and ISO 13485, and 9001 (preferred)
- Ability to quickly differentiate between issues that can be resolved at this level and those that should be referred to a higher authority
- Investigative skills required to perform trend analyses and failure investigations
- Tactical management and people skills are required and applied in the supervision of employees and negotiation with the Company’s employees in other departments
- Perform all work in compliance with company policy and within the guidelines of the Company’s Quality System
- Set priorities for workload and delegation of tasks
- Appraise performance of employees against job duties, objectives and projects
- Assist with the development and implementation of Quality system policies
- Monitor, review and track customer complaints through the RMA tracker, and work with the Assoc. of Director of Quality and other key stakeholders in the prompt resolution of significant quality issues
- Interface with the other department managers to communicate status, priorities and/or problems
- Verify and validate activities for internal and external software as required
- Maintain Device History Records
- Maintain Training Plans and Training records
- Provide on-going support to ensure training proficiency requirements as defined by ISO and FDA guidelines are meet and /or exceeded
- Responsible for all Quality Web (QW) approvals associated with department specific WIDS and Validations (equipment, software, batch records, etc.)
- Attend both regularly scheduled and required meetings as a representative of the QA team that encompass key areas with the scope of your responsibility
- Perform other duties as assigned
Headquartered in Augusta, Georgia and founded in 1973, MAU Workforce Solutions is a multi-faceted business solutions provider offering professional recruiting, commercial staffing, outsourcing, and human resources services. World class companies across the globe utilize our customized workforce solutions in order to gain a competitive advantage.
MAU is a family-oriented organization that has built its foundation upon strong values of dedicated service, loyal relationships and tailored business solutions all of which still remain today.
Disclaimer: All applicants must submit to background check and drug screening.
This position does not offer sponsorship
Equal Opportunity Employer
Minorities / Females / Protected Veterans / Individuals with Disabilities are encouraged to apply