Medix is seeking a proven, quality-minded individual who possesses strong design controls and risk management experience to support a regulated production team that we work with in Hartland, WI. If you're a Quality professional seeking their next challenge, consider applying today and let's connect!
Job Summary
Responsible for managing the quality and compliance for applicable products and processes for assigned department(s). Adapt departmental plans and priorities to address resource and operational challenges.
Major Responsibilities
Ensure quality and regulatory compliance with applicable regulations (e.g., QSR, GMP, ISO) pertaining to the applicable life cycle and regions of distribution for the product.
Act as a liaison with Divisions, Suppliers, Manufacturing, and/or Operations to ensure quality products and customer satisfaction.
Manage complaints and develop new approaches to solve problems identified during the investigation process.
Identify and manage the execution of continuous improvement projects.
Assist the division in product evaluation from a quality assurance and regulatory compliance standpoint. Assist in the planning of design, testing, inspection, and process validations to ensure quality products or components.
Ensure all quality issues are resolved to customer satisfaction in a timely manner.
Resolve issues relating to product or production quality by interfacing with internal and external customers.
Management Responsibilities
Typically oversees professional employees/teams OR manages non-professional employees through Supervisors in manufacturing, distribution, or office environments.
Recommend and implement new policies or modifications to existing policies.
Provide general guidelines and parameters for staff functioning.
Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, and ensuring consistent application of organizational policies.
Job Requirements
Bachelor's degree in Engineering, Science, or a Technical Field.
At least 4 years of experience related to the design/operation of medical device or drug combination product platforms, design controls, risk management, including working in compliance with QSR/GMP/ISO requirements or other regulated industries (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR).
At least 2 years of supervisory/managerial experience preferred.
Broad technical knowledge of relevant standards and regulations (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR etc.).
Advanced level skill in Microsoft Excel (e.g., using AVERAGE function, merging and centering cells, printing centered page, and/or creating a pivot table).
Position requires travel up to 25% of the time for business purposes (within state, out of state, and/or internationally).