Job Summary:

The Quality Control Coordinator will be responsible for a variety of activities to support production from a quality and regulatory perspective.This includes but is not limited to performing inspections; ensuring accurate production floor documentation; validation of material receipt and returns; and supporting overall quality improvements in production.

Responsibilities (Specific tasks, duties, essential functions of the job)

• Perform incoming inspection of received materials and components.




• Conduct Material Review Board (MRB) for parts rejected at incoming inspection, production and field returns.




• Perform Device History Record (DHR) review and product release.




• Ensure production floor documentation is accurate and complete.




• Create debit memos for Return to Vendor (RTV) of non-conforming material.




• Assist Accounts Payable with RTV credits that do not coincide with vendors.




• Perform audits and inspection of work instructions and of standard operating procedures.




• Ensure strict compliance to cGMP, current Good Manufacturing Practices.




• Inspect goods to ensure customer expectations are met.




• Review Bill of Materials (BOM’s) prior to the beginning of a production run.




• Conduct line clearance audits prior to production operations.




• Record, correct and re-test out of specification results.




• Participate in manufacturing process validations as needed.




• Ensure cleanliness of production areas and report any unacceptable details to Shift Supervisor.




• Perform quality audits and product audits as specified to verify product




• Perform evaluations and qualifications of production and quality assurance equipment as needed




• Coordinate calibration and maintenance of production and quality assurance equipment




• Participate in manufacturing process validations as needed




• Assist Quality Engineer (QE) in root cause investigations for non-conforming parts




• Work with Quality Engineer to help resolve internal and external audit corrective and preventative actions




• Support the Quality Engineer in the performance of vendor assessments and recommendations




• Fulfill back-up duties as needed for the Quality Engineer




• Track MRB metrics to direct workload for MRB team




• Contact vendors to address quality concerns




• Direct the day-to-day activities of all QC’s




• Ensure the safety and well-being of all Quality associates




• Maintain regular and punctual attendance.




• Comply with all company policies and procedures.




• Assist with any other duties as assigned.

Knowledge, Skills, and Abilities

• Must have strong work ethic.




• Excellent oral and written communication skills required.




• Inventory management knowledge




• Ability to read and interpret design criteria including technical drawings, blueprints, and manufacturing instructions required




• Must be competent with using basic precision inspection tools




• Attention to detail is required.




• Effective conflict resolution.




• Analytical & problem-solving skills & ability to multi task.




• Solutions-oriented problem solver.




• Excellent planning, communication and organizational skills.




• Ability to effectively interface with different departments within the company.

Qualifications (Experience and Education)

• Able to execute at a project + strategic planning level.




• No/minimal supervision required, able to make decisions.




• Will be able to mentor/train junior staff members.




• Associates degree in a technical discipline, preferred.




• 6+ years of experience in quality assurance, required. Preferably in medical device manufacturing.




• 2+ years’ experience in a manufacturing leadership role, preferred.




• Advanced knowledge/proficiency Microsoft Office, required.




• Advanced Excel skills, required.




• A combination of training, education and experience that is equivalent to the qualifications listed above and that provides the required knowledge, skills, and abilities.