Key Responsibilities :
- Graphics and Labeling Requirements : Evaluates, edits, and formulates label content according to customer specifications and company protocols.
- Assumes responsibility for label management and reconciliation processes, ensuring accurate documentation of label application and disposal.
- Assists Speed to Market teams during product transfers and collaborates with Production teams on product alterations.
- Updates job jackets, MOM, and related documents to implement product modifications based on reviewed revisions.
- Reviews and supports the assessment of material non-conformances, ensuring proper segregation, disposition, and corrective actions before material release.
- Investigates and addresses customer returns, complaints, and support requests regarding product conformity, implementing necessary corrective actions promptly.
- Review and investigates requested or assigned Corrective Action Requests (CARs) and Corrective and Preventive Actions (CAPAs).
- Supports or conducts compliance audits of Quality System processes, manufacturing areas, and documentation as directed.
- Presents audit findings to process or area management and company leadership as required.
- Assists the Quality System Manager in overseeing external audits from customers and regulatory bodies.
- Manages equipment and gauge calibration resources, ensuring compliance with calibration procedures.
- Supports the maintenance and control of measurement equipment, conducting periodic inspections for usability and addressing user queries or concerns.
- Provides support for equipment preventive maintenance scheduling and work standard enforcement.
- Collaborates with the organization to develop work standards in line with production transfer and improvement initiatives.
- Facilitates air, water, and surface monitoring for viable and particulate counts, coordinating with external suppliers for cleanroom and HEPA testing.
- Contributes to Quality objectives relevant to job responsibilities.
- Undertakes additional duties as assigned by the immediate supervisor.
- Job Closing Responsibilities : Reviews MOM for customer documentation requirements, excluding references to CoCs.
Qualifications : Education and Experience :
- Bachelor's Degree in Life Sciences or a related technical discipline (e.g., biomedical engineering) or field.
- Minimum of 5 years of experience in an ISO 13485 environment.
- Minimum of 5 years of direct experience in nonconformance and CAPA investigation within the medical device industry.
- Previous experience supporting and facilitating internal and external audits within the medical device field.
Certificates, Licenses, Registrations :
Certification as a quality auditor or similar industry certification.
Benefits :
Full-time team members become eligible for benefits starting the first day of the month following 30 days of employment. These include :
- Health Insurance :
- High Deductible Health Plan (HDHP) with Health Savings Account (HSA) - with an employer contribution of $1,040 annually.
- High Preferred Provider Organization (PPO)
- Low Preferred Provider Organization (PPO)
- Flexible Spending Account (FSA)
- Dental Insurance
- Vision Insurance
- Basic Life Insurance (Employer-paid)
- Supplemental Life Insurance
- Short-term Disability Insurance (Employer-paid)
- Long-term Disability Insurance
- 401(k) Plan with a 4% Employer Match
- Paid Time Off (accrued at 120 hours per year)*
- 9 Paid Holidays
- Access to Continuing Education and Seminar Programs
- Employee Assistance Program (EAP)
- Fitness Room Access
30+ days ago