Sr. Quality Assurance Specialist
POSITION SUMMARY:
The Sr. Quality Assurance Specialist (SQAS) is responsible for executing and supporting Quality System requirements in maintaining a compliant Quality System (ISO, FDA 21 CFR 820, etc.). Specifically, this role is responsible for creating procedures, assessing changes to procedures, auditing for compliance to procedures, leading CAPA system activities and recall activities, where required.
PRIMARY DUTIES & RESPONSIBILITIES:
• Create and update quality system procedures, including leading and performing biennial reviews to drive continuous improvement, align best practices, procedures and applicable regulations (FDA, ISO, etc.)
• Responsible for leading impacts resulting from proposed changes to quality system procedures
• Supports standards review process by continuously monitoring regulations and guidance documents for required updates
• Responsible for processing quality system, marketing collateral, and product documenting engineering change orders, reviewing for completeness and releasing controlled copies for use.
• Leads and performs internal and supplier quality system audits (for areas independent of responsibilities)
• Supports Master Audit Schedule, vendor management and leads onsite/desktop audits, and post market surveillance activities as needed
• Executes health hazard evaluations and field action activities with direction from the Recall Coordinator. Identify scope of product holds, perform traceability, and physical quarantine of impacted products.
• Supports timely execution of Quality Plans, Quality System CAPAs, CAPA trending meetings and management reviews
• Investigate potential non-conformances and recommend CAPA activity to manager. Leads CAPA investigations for root cause determination and action implementation/verification.
• Distribute documents for approval and obtain signatures from team members (DocuSign)
• Supports external (FDA, ISO, etc.) compliance audits as well as schedule and manage internal audits as required to maintain quality compliance
Qualifications
• An associate or bachelor’s degree in life sciences is strongly preferred; in lieu of degree, a HS Diploma with 7+ years of quality experience in the medical device or related industry is required.
• A minimum of 5+ years’ experience in medical device or pharma quality systems role (e.g. Document Control, Quality Control, Quality Assurance, etc.) is required
• Prior root cause analysis training is preferred
• Quality system auditor training or certification is preferred (ISO, other)
Additional Information
All your information will be kept confidential according to EEO guidelines.
It is Treace’s policy not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, veteran status or any other characteristic protected by applicable law. EEO/Disabled/Veterans Employer
Treace is a drug free employer.