Quality Control Manager

Duties/Responsibilities:

· Effectively maintain a paper-based Quality Management System

· Conduct regular document reviews to recommend, initiate, implement, and verify solutions for continuous quality and process improvement with the appropriate approval.

· Evaluate and report on the effectiveness and implementation of the quality system.

· Conduct annual risk management reports for Product Realization Activities

· Monitor regulations and standards to ensure prompt responses to any changes

· Coordinate with the VP of Sales & Marketing to ensure effective Supplier Performance Monitoring and Management

· Provide training to personnel performing quality-related activities and maintain the training matrix

· Coordinate with vendors for proper calibration of all monitoring and measuring devices

· Coordinate and supervise internal and external audit activities to verify essential quality characteristics.

· Ensure effective closure of audit activities by working with auditees to ensure comprehension, development, and execution of corrective/preventive action regarding any nonconformities.

· Review inspection results for accuracy and compliance with established requirements.

· Investigate device complaint records and examine returned goods to verify non-conforming conditions and implement corrective actions as appropriate.

· Authority to stop product processing, release, and distribution.

· Participate in and document Management Reviews

· Work daily with the Warehouse & Shipping Coordinator to prepare and ship the final product.  Average of 2 to 3 hours per day with some days each month of 5 to 6 hours.

Required Skills/Abilities:
· Demonstrated understanding of cGMP, ISO 13485: 2016 and IVDR

· Ability to effectively advocate a strategic quality systems approach.

· Ability to work effectively with all departments to ensure conformance to regulatory requirements, internal processes, and policies.

· Strong written and verbal communication skills

· Strong knowledge of Microsoft Office

· Ability to prioritize tasks to meet deadlines

Education/Experience:
· Bachelor’s Degree required

· Experience in maintaining an ISO 13485: 2016 quality management system and training program preferred.

· Internal or external auditing experience in medical devices or other regulated manufacturing environments preferred.

Physical Requirements:
· Must be able to handle packages weighing 50 lbs routinely.  (occasionally more)

· Prolonged periods of sitting and working on a computer

· Prolonged periods of standing

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off

Schedule:

• 8-hour shift

Supplemental Pay:

• Bonus pay

COVID-19 considerations:
We are a 100% employee-vaccinated facility.  A Masking policy is in effect currently.

Ability to commute/relocate:

• Broomall, PA 19008: Reliably commute or planning to relocate before starting Work (Required)

Experience:

• ISO 13485: 1 year (Preferred)

Work Location: One location