Quality Systems Engineer

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