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Medical Device Quality Control Manager
2 months ago
Medical Components, Inc. is seeking a highly skilled and experienced Medical Device QC Supervisor to join our team. As a key member of our quality team, you will play a crucial role in ensuring that our medical devices meet the highest standards of quality and regulatory compliance.
Job Summary:The Medical Device QC Supervisor will be responsible for leading a team of quality control inspectors and technicians, overseeing daily operations, and ensuring that products are tested, inspected, and verified according to established protocols. You will work closely with cross-functional teams to identify and implement process improvements, ensuring that our products meet the required standards of quality, reliability, and performance.
Key Responsibilities:- Establish and maintain quality control procedures, standards, and specifications for the release of finished goods.
- Manage the quality control activities, including staff supervision, training, and development.
- Ensure that staff completes QC tasks associated with inspecting and testing products accurately and in accordance with SOPs.
- Prepare, communicate, and evaluate team goals and objectives for continual improvement of the efficiency and effectiveness of the quality system.
- Respond to customer inquiries and submission support.
- Participate and/or support both internal and external audits.
- Manage the NCR process by conducting investigations and assisting the Quality Assurance group as needed.
- Responsible for QC budget.
- Support FDA and Notified body inspections and regulatory, quality, and customer audits as necessary.
- Develop and implement departmental training. Ensure all training is completed and up to date.
- Manage and delegate workflow to team members.
- Continuously look to improve the QC department and its functionality.
- Provide guidance and advice on methods, procedures, standardization, and requirements.
- Root cause analysis and implementation of corrective action for process-related concerns.
- Analyze failure, corrective, and preventive action to respond to internal/external customer complaints as needed.
- Report out (track/trend) of QC department metrics on a routine basis.
- Ensure incoming and in-process inspection records are completed and are accurate.
- Ensure QC documents are completed following GDP.
- Ensure products are manufactured following GMP.
- Ensure adherence to health and safety guidelines.
- Bachelor's degree (B.A.) from four-year college or university; or 3-5 years related experience and/or training; or equivalent combination of education and experience.
- Audit certification and/or auditing experience is preferred.
- Knowledge and experience with ISO 13485 and other recognized quality systems.
- Prefer 3 years supervisory/management experience.
- Working knowledge of national and international regulations applicable to medical devices including Quality System Regulations, 21 CFR 820, Medical Device Regulation (MDR) 2017/745, MDD 93/42/EEC, Canadian Medical Device Regulations, ISO 14971, ISO 13485, QSIT or combination of is preferred.
- Excellent writing skills and presentation skills.
- Prior experience in medical device manufacturing environment coupled with certifications from ASQ preferred.
- Ability to analyze and interpret all regulatory and quality guidelines.
- Demonstrate a strong 'business partner' approach and attitude providing creative and innovative solutions that meet quality standards.
Medical Components, Inc. develops, manufactures, markets, and supports cutting-edge vascular access devices and accessories to meet the clinical needs of the medical industry, particularly in the fields of interventional medicine and dialysis. Our company's engineering and applications expertise provides superior products whose progressive designs accommodate advances in medicine and whose quality anticipates the requirements of our professional clients and the patients they serve.
Our Offerings:- Competitive compensation
- Health, Dental, Vision coverage
- FSA
- Life Insurance
- 401k
- Paid Holidays
- Generous PTO
We offer meaningful rewarding work to our team members by providing a culture that is built on and supported by practicing our core values, and by providing our team members with the tools and resources they need to succeed.
We are committed to ensuring equal employment opportunities for all job applicants and employees. Employment decisions are based upon job-related reasons regardless of an applicant's race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, marital status, genetic information, protected veteran status, or any other status protected by law.
