Quality and Compliance Manager
- Job Title
- Quality and Compliance Manager
- Job ID
- Athens, TX, TX
- Other Location
Quality and Compliance Manager, Athens, TX.
We are hiring for a Quality and Compliance Manager to join our Quality Department at our Manufacturing Facility located in Athens, TX.
Job Description: Quality and Compliance Manager will work to apply knowledge in the implementation of an integrated Quality System to ensure full compliance and a continual product, process, and supplier improvement culture. This individual will work closely with all cross-functional teams to create quality strategies that support customer needs and overall business objectives. Work on and provide solutions to a wide range of difficult problems relating to the quality aspects of design, validation (IQ/OQ/PQ), and manufacture of medical devices. Oversees and directs the activities of inspection team and quality engineers to achieve plant quality objectives.
The Quality and Compliance Manager serves as owner and administrator of several aspects of the quality system, including but not limited to supplier management, customer feedback, process control, internal audits, change management, and design control. This quality and compliance professional will be responsible for the Quality Assurance function of Argon product lines and assuring conformance to product specifications in a global supply chain environment and will serve as site Management Representative (21 CFR 820, ISO 13485:2016) and Responsible Engineering Manager (JPAL) for regulatory inspections.
Quality and Compliance Manager Education and Experience Requirements:
- Bachelor’s Degree in science, math, or engineering discipline
- Minimum 7 - 10 years of work experience in regulated healthcare environment (ISO 13485:2016/ and 21CFR 820, EU MDD and MDR); past management of Notified Body and FDA/MDSAP audits
- Preferred process experiences include grinding, machining, coatings, cleaning, packaging, computer-generated labeling, clean room manufacturing, injection molding
- Strong validation/verification skills for equipment and processes
- Experience with PFMEA/FMEA and ISO 14971 Risk Management
- CQA or CBA or RABSQA, CQE required. CQMgr/OE, Lean, CSSGB/CSSBB certifications preferred
- Minitab software or similar statistical analysis software tool; General Microsoft Office applications
- Prior experience implementing eQMS solutions preferred
The Quality and Compliance Manager will be responsible for the implementation of systems for product quality standards and procedures, including in-coming material quality, in-process product quality, and out-going product quality plans, Document Control, CAPA, Complaint handling, Internal Audits, and Supplier Quality. The role will provide technical input for the organization regarding all quality matters. Keep abreast of developments affecting the QA aspects of the organization to recommend changes to current programs or new programs resulting from such development. This individual will manage, lead, and develops QA staff to ensure compliance with all Argon and government regulatory/statutory requirements while facilitating continual systems improvement; facilitates and performs internal/external audits, as required.
Argon Medical is a global manufacturer of specialty medical products, including a broad line of medical devices for Interventional Radiology, Vascular Surgery, Interventional Cardiology, and Oncology. With over 800 employees worldwide. Argon has manufacturing facilities located in Athens, TX, Wheeling, IL and Rochester, NY. Argon’s brand is recognized for best-in-class products that improve patient outcomes via percutaneous, image-guided procedures. https://www.argonmedical.com/about/our-company
- Required Skills
• Bachelor’s Degree in science, math, or engineering discipline
• Minimum 7 - 10 years of work experience in regulated healthcare environment (ISO 13485:2016/
and 21CFR 820, EU MDD and MDR); past management of Notified Body and FDA/MDSAP audits
• Preferred process experiences include grinding, machining, coatings, cleaning, packaging,
computer-generated labeling, clean room manufacturing, injection molding
• Strong validation/verification skills for equipment and processes
• Experience with PFMEA/FMEA and ISO 14971 Risk Management
• CQA or CBA or RABSQA, CQE required. CQMgr/OE, Lean, CSSGB/CSSBB certifications preferred
• Minitab software or similar statistical analysis software tool; General Microsoft Office applications
• Prior experience implementing eQMS solutions preferred