Quality Assurance Manager- Med Device - Milford, United States - BioLink 360

BioLink 360 Milford, United States

1 week ago

Description

Position title:
Quality/QMS Manager- Southern CT

Reports to:
Director of Operations

Position type:
Hybrid

Salary:
K

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.

Responsibilities

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.
Develops and evaluates complex measurements systems, implementing sampling strategies and control plans.

Qualifications
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.

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