Quality Assurance and Regulatory Affairs Manager

Location: This position will be on-site full-time in Grand Rapids, MI.

Applicants must be authorized to work for any employer in the U.S. At this time, we are unable to sponsor or assume sponsorship of an employment visa.

The Quality Assurance & Regulatory Affairs Manager plans, directs and coordinates the development, application, and maintenance of all quality systems for inspecting incoming product, raw material, in-process material and products through finish product. Oversees and directs plans, organizes and develops test plans, prepares test data and subsequent testing of all products. Responsible for managing data during product development and evaluation prior to product release. Responsible for customer, ISO audits and for organizing compliance to regulatory requirements related to manufacturing medical devices. Manages 4-6 Quality Engineers and Quality Technicians. Additionally, this role oversees regulatory affairs activities, ensuring compliance with applicable local and international regulations. The manager is responsible for maintaining regulatory documentation, supporting regulatory submissions, and serving as a liaison with regulatory agencies.

• Develops and documents quality plans for new and existing products.
• Monitors and controls quality systems to ensure effectiveness, efficiency and compliance.
• Analyzes quality control test results and provides feedback and interpretation to production management or staff.
• Supports manufacturing and engineering problem solving efforts on in-process and vendor related quality issues.
• Communicates quality control information to all relevant organizational departments, outside vendors and contractors.
• Investigates customer returns and complaints. Oversees development and implementation of corrective action measures to prevent re-occurrences.
• Implements procedures to assure that products comply with customer specifications.
• Coordinates, as needed, the administration of the defective material identification & disposition program; i.e., the PMDR & MRB program.
• Monitors & takes corrective/improvement action on key quality measurables; i.e., parts per million (PPM), repeat complaints.
• Performs or delegates the quality department functions defined in our APQP process.
• Assures control plans and checking methods and tools therein, are meaningful and effective.
• Provides training to manufacturing personnel to assist in the preparing definition and monitoring of quality requirements.
• Monitors existing business practices to ensure compliance with existing policies and procedures (ISO compliance).
• Serves as the quality management representative, representing the quality management system to external organizations.
• Supports product development and transfer into production to ensure process capability exists and product requirements are understood.
• Participates in conducting both internal and vendor audits; including 2^nd and 3^rd party quality system audits.
• Supports purchasing in supplier performance measurement.
• Oversees and directs activities of quality department staff in support and maintenance of quality systems.
• Manages individual performance providing coaching, mentoring and performance feedback to ensure that plant objectives are achieved. Instructs and mentors quality staff in quality control and analytical procedures.
• Generates and maintains quality operating budgets.
• Develops and implements quality training programs to train employees to the appropriate and necessary quality systems, techniques and methods including ISO 13485, IATF 16949, and Core Tools.
• Produces reports regarding nonconformance of products or processes, daily production quality, root cause analyses and quality trends.
• Manages internal/external calibration of all required measurement devices, gauges and testing equipment.
• Ensures the QMS includes all Customer Specific Requirements as appropriate.
• Recommends technical hardware and software as appropriate in support of the annual business plan
• Annually provides production quantities to the EPA in support of customer FHCS.
• Ensures all regulatory requests (REACH, RoHS, TSCA, PFAS etc.) from UFP customers are responded to as appropriate.
• Assists other plants in assuring quality systems are in compliance, as required.
• Ensures compliance with medical device regulations including local (FDA) and international regulations (ISO 13485, MDSAP, MDR, etc.).
• Familiar with the preparation and maintenance of regulatory documentation and submissions such as 510(k)s, CE technical files, and product registrations.
• Acts as the primary liaison with regulatory agencies during inspections, audits, and correspondence.
• Continuously monitors changes to regulatory requirements and updates internal processes and documentation accordingly.
• Supports post-market surveillance activities, including adverse event reporting and field action coordination, as required by regulatory authorities.
• Performs all other duties as assigned or needed.

UFP Technologies, Inc. is an Equal Opportunity/Affirmative Action employer Minorities/Women/Veterans/Disabled.

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