Position title: Quality/QMS Manager- Southern CT
Reports to: Director of Operations
Position type: Hybrid
We are seeking a dynamic Quality leader with life science background. This is a long standing company, privately held medical device company that is a leader in their space. We are looking for a Quality Manager who will have responsibility over all things Quality, and work closely with the Senior Leadership team as an in house subject matter expert.
• Develops and implements quality systems and practices to assure compliance with FDA, ISO and other required regulatory bodies, serving as the company Quality Management Representative.
• Manages the development and implementation of goals, objectives, policies, procedures, and systems. Communicates quality goals, metrics, and standards to the organization
• Identify quality related organization wide training needs and develop programs. Assist in delivering training.
• Develops customer and internal inspection-based metrics. Identifies trends and develops action plans.
• Monitors supplier quality performance and initiates programs to ensure suppliers meet organization and customer expectations.
• Assists in program launch, process qualification and equipment validation.
- Bachelor's degree (B. S.) in Mechanical Engineering or related technical field or equivalent related experience.
- Minimum of 8 years experience in quality engineering in the medical device, dentistry, veterinary medicine or similar industry.
- Statistical problem solving, statistical sampling technique, SQC, SPC and higher-level statistical problem solving (DOE, t Test, f Test, etc.).
- Experience in materials science, material specification and tolerancing and raw material processing technique.
- Experience with manufacturing processes in a high-volume, tight tolerance precision manufacturing environment.
- Management and supervisory experience required.
- ISO 13485 quality system or equivalent experience.