Argon Medical Devices Inc
Quality & Compliance Manager
Argon Medical Devices Inc, Wheeling, Illinois, United States, 60090
Company Overview:
Argon Medical is a global manufacturer of specialty medical products, headquartered in Plano, Texas. Argon offers a broad line of medical devices for Interventional Radiology, Vascular Surgery, Interventional Cardiology, and Oncology. Argon’s brand is recognized for best-in-class products that improve patient outcomes via percutaneous, image-guided procedures. Our values describe what we believe in and how we operate. These values are our moral compass which guide our decisions and define the deeply held beliefs and principles of our organizational culture. Argon Medical is a family of individuals united by a mission and culture which continue to grow stronger every day.
ARGON MEDICAL DEVICES IS NOT LEVERAGING SEARCH FIRMS
Position Overview:
The Quality & Compliance Manager will work closely with all functions to create quality strategies that support customer needs and overall business objectives. Will provide solutions to a wide range of difficult problems relating to the quality aspects of design, validation, and manufacturing of medical devices. Serve 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.
What you will do:
Responsible for the Quality Assurance function of Argon product lines and assuring conformance to product specifications in a global supply chain environment.
Serve as the management representative (21 CFR 820, ISO 13485) and Responsible Engineering Manager (JPAL) for regulatory inspections.
Responsible for the implementation of systems on 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.
Performs Adverse Event (AE) Evaluation to determine reportability according to 21 CFR Part 803, Canadian Medical Devices Regulations (SOR/98-282), and MEDDEV 2.12-1 requirements and new EU MDR.
Manages, leads 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.
Support implementation of Validation Master Plan; participate in process/product validation (IQ/OQ/PQ) activities including review and approval of protocols and test reports; support design transfer activities for licensed products.
Provide technical input for the organization regarding all quality matters.
Interpret, organize, execute and coordinate assignments relating to quality including providing direction to other technical staff.
Skills for Success:
Bachelor’s degree in science, math or engineering discipline.
CQA or CBA or RABSQA, CQE certifications required (CQMgr/OE, Lean, CSSGB/CSSBB certifications preferred).
Minimum 7 - 10 years of work experience in regulated healthcare environment.
Experience in the transfer of design to manufacturing including coordination with sister companies.
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.
Measurement Systems Analysis, Gage R&R and development of inspection test methods.
Previous success leading and mentoring a team in a collaborative environment.
Must possess strong analytical and problem-solving skills.
Ability to prioritize for maximum results (multi-task management).
Function successfully in a high-paced results-oriented team environment.
Self-motivated, quick learner, productive team member.
Must have excellent communication skills (verbal and written).
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Argon Medical is a global manufacturer of specialty medical products, headquartered in Plano, Texas. Argon offers a broad line of medical devices for Interventional Radiology, Vascular Surgery, Interventional Cardiology, and Oncology. Argon’s brand is recognized for best-in-class products that improve patient outcomes via percutaneous, image-guided procedures. Our values describe what we believe in and how we operate. These values are our moral compass which guide our decisions and define the deeply held beliefs and principles of our organizational culture. Argon Medical is a family of individuals united by a mission and culture which continue to grow stronger every day.
ARGON MEDICAL DEVICES IS NOT LEVERAGING SEARCH FIRMS
Position Overview:
The Quality & Compliance Manager will work closely with all functions to create quality strategies that support customer needs and overall business objectives. Will provide solutions to a wide range of difficult problems relating to the quality aspects of design, validation, and manufacturing of medical devices. Serve 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.
What you will do:
Responsible for the Quality Assurance function of Argon product lines and assuring conformance to product specifications in a global supply chain environment.
Serve as the management representative (21 CFR 820, ISO 13485) and Responsible Engineering Manager (JPAL) for regulatory inspections.
Responsible for the implementation of systems on 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.
Performs Adverse Event (AE) Evaluation to determine reportability according to 21 CFR Part 803, Canadian Medical Devices Regulations (SOR/98-282), and MEDDEV 2.12-1 requirements and new EU MDR.
Manages, leads 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.
Support implementation of Validation Master Plan; participate in process/product validation (IQ/OQ/PQ) activities including review and approval of protocols and test reports; support design transfer activities for licensed products.
Provide technical input for the organization regarding all quality matters.
Interpret, organize, execute and coordinate assignments relating to quality including providing direction to other technical staff.
Skills for Success:
Bachelor’s degree in science, math or engineering discipline.
CQA or CBA or RABSQA, CQE certifications required (CQMgr/OE, Lean, CSSGB/CSSBB certifications preferred).
Minimum 7 - 10 years of work experience in regulated healthcare environment.
Experience in the transfer of design to manufacturing including coordination with sister companies.
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.
Measurement Systems Analysis, Gage R&R and development of inspection test methods.
Previous success leading and mentoring a team in a collaborative environment.
Must possess strong analytical and problem-solving skills.
Ability to prioritize for maximum results (multi-task management).
Function successfully in a high-paced results-oriented team environment.
Self-motivated, quick learner, productive team member.
Must have excellent communication skills (verbal and written).
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