Location: Spencer, Indiana (US-IN), United States (US)
Additional Locations: (n/a)
Hiring Manager: Adrian Crespo Llobet
Recruiter: Spencer Gregory Hale
Quality Manager I
About the role:
Develops, establishes and maintains quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to establish standards and agency guidelines to ensure lasting customer satisfaction. Reviews, analyzes and reports on quality discrepancies related to assembly, process and product function systems and develops disposition and corrective actions for recurring discrepancies. Interfaces with manufacturing, engineering, customer, vendor and subcontractor representatives to determine responsibilities and solutions. May serve as liaison between the company and the various governmental agencies. Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications. Establishes and ensures compliance with good housekeeping practices, employee hygiene and equipment sanitation; analyzes plant error, salvage, spoilage reports and process statistics for significant findings and conclusions; works with Research and Development during new product start-ups, and establishes key checkpoints for new products and processes.
Your responsibilities include:
• Assists in and/or manages functional deliverables and ensures technical excellence for product or technical development.
• Supervise the Incoming Quality laboratory, Post-Production Quality Assurance and Record Retention.
• Provides guidance and approval regarding quality strategies and approaches.
• Provides guidance and training to staff, assists subordinates in attaining career goals, motivates individuals to achieve results, and recruits and maintains a high quality staff.
• Assists in and/or completes the development of budgets and monitors spending.
• Assists in identifying and developing department tools.
• Assists in and/or determines appropriate staff levels, schedules and resources. Works with project managers to understand priorities and plan resource and time allocation accordingly.
• Maintains and enhances cross-functional team relationships.
• Works cross-functionally in identifying and resolving technical issues.
• Monitors and evaluates project and department progress and results.
What we are looking for in you:
• BS in Mechanical, Electrical, Biomedical Engineering or related engineering degree
• Minimum of 8 years in Medical device engineering experience.
• In depth familiarity with the FDA, ISO, MDD, EU MDR and the medical device industry quality requirements associated with product development, design controls, and product risk management.
• Detailed understanding and working knowledge of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required, as well as the Medical Device Directive, EN ISO 13485, EN ISO 14971, IEC 60601, and EN 62366.
• Strong communication and presentation skills.
• Competent with use of Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent).
• MS degree
• 10+ years medical device engineering experience
Requisition ID: 496323