Quality & Compliance Manager

Argon Medical Devices - Wheeling, IL

Full-time - Mid Level

Wheeling, IL

1,001-5,000 employees

Miscellaneous Manufacturing

About the position

The Quality & Compliance Manager at Argon Medical is responsible for developing and implementing quality strategies that align with customer needs and business objectives. This role involves overseeing the quality assurance function for medical device product lines, ensuring compliance with regulatory standards, and managing various aspects of the quality system, including supplier management and internal audits.

Responsibilities

• 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 for regulatory inspections (21 CFR 820, ISO 13485) and Responsible Engineering Manager (JPAL).
• Implement systems on product quality standards and procedures, including incoming material quality, in-process product quality, and outgoing product quality plans.
• Manage Document Control, CAPA, Complaint handling, Internal Audits, and Supplier Quality.
• Perform Adverse Event (AE) Evaluation to determine reportability according to regulatory requirements.
• Lead and develop QA staff to ensure compliance with regulatory/statutory requirements and facilitate continual systems improvement.
• Support implementation of Validation Master Plan and participate in process/product validation activities.
• Provide technical input regarding all quality matters and coordinate assignments relating to quality.

Requirements

• 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 a regulated healthcare environment.
• Experience in the transfer of design to manufacturing, including coordination with sister companies.
• 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.
• Strong analytical and problem-solving skills.
• Ability to prioritize for maximum results in a high-paced environment.
• Excellent communication skills (verbal and written).

Nice-to-haves

• Experience in grinding, machining, coatings, cleaning, packaging, computer-generated labeling, clean room manufacturing, injection molding.