As a Quality Control Supervisor at Medical Components, Inc you will play a crucial role in ensuring that our medical devices meet the highest standards of quality and regulatory compliance. You will lead a team of quality control inspectors and technicians, overseeing daily operations and ensuring that products are tested, inspected, and verified according to established protocols. Your leadership and expertise will help maintain our commitment to excellence and safety in the medical device industry. This position is responsible for ensuring incoming components and manufactured products meet set standards of quality, reliability and performance, in adherence with ISO 13485, FDA 21 CFR Part 820 as well as other country regulations within the medical device industry.
Essential Duties and Responsibilities – other duties may be assigned as necessary.
- Establish quality control procedures, standards, and specifications for the release of finished goods
- ensure that the company’s processes and products are in compliance with applicable quality standards and requirements.
- Manages the quality control activities, including staff.i.e.,
- Approve/Deny PTO requests
- Timecard approval
- Recruitment activities, such as interviewing
- Disciplinary matters
- Conduct Performance Reviews
- Ensures staff completes QC tasks associated with inspecting and testing products is completed accurately and SOPs are followed
- Prepare, communicate, and evaluate team goals and objectives for continual improvement of the efficiency and effectiveness of the quality system along with providing individuals with professional growth
- Respond to customer inquiries and submission support
- Participate and/or support both internal and external audits
- Participates in project performance team meetings on behalf of the job unit in order to provide ideas, methods, or processes for unit/company performance improvement
- Responsible for the management of data and presentation of data to management to support Management Review
- Develop improvements within the QC department, including training, SOPs, etc
- Collaborate with sister companies as well as internal and external customers, vendors and suppliers
- Collaborate with internal departments regarding external testing requirements
- Support internal departments regarding QC needs
- 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
Supervisory Responsibilities
Directly supervises the QC Departments. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Education And/or Experience
- 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
About Us - Medcomp® 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. Currently one of the world's largest manufacturers of dialysis and centrally terminating venous catheters, Medcomp is, and always has been, on the cutting edge of new vascular access device technologies.
Our offerings have our Team Members’ well-being in mind.
- Competitive compensation
- Health, Dental, Vision coverage
- FSA
- Life Insurance
- 401k
- Paid Holidays
- Generous PTO
What you will get from us:
VISION & MISSION STATEMENT
To be the leading solution provider for every customer we serve.
To drive sustainable growth of our business through the continued investment in our people, technology and quality while delivering world class products and services.
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.
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