Pirouette Medical · 2 days ago

Director of Quality Assurance

Boston, MA

Full-time

Hybrid

Director

$150K/yr - $200K/yr

10+ years exp

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Health CareMedical Device

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Responsibilities

Develops, implements, and maintains company’s quality assurance programs; establishes quality standards/metrics/objectives; develops methods to embed quality into the product development and manufacturing process.

Qualifies and establishes vendor relationships and quality standards by developing and implementing innovative programs to focus employees on improving product quality.

Creates a quality culture while utilizing business acumen with cross functional departments.

Ability to communicate and educate suppliers in Pirouette Medical’s quality philosophy in every step of the manufacturing process.

Manages and maintains assigned budgets and communicates changes in the established budget rapidly.

Other duties as assigned, according to the changing needs of the business.

Qualification

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Quality AssuranceQuality EngineeringLife SciencesDrug Device Combination ProductsProduct Development LifecycleAuditsComplianceNotified BodiesQMS21 CFR 820ISO 1348521 CFR 211LeadershipProblem-SolvingTeamworkSelf-Starter

Required

Bachelor's Degree required in a science or engineering discipline or related field.

10 years or more of progressive and demonstrated leadership experience in Quality Assurance or Quality Engineering in the life sciences arena.

Experience working with drug device combination products highly preferred. Experience with all phases of the product development lifecycle.

Demonstrated history of success in audits and compliance, and interaction with notified bodies.

Experience working with QMS compliant to 21 CFR 820, ISO:13485, and 21 CFR 211.

Experience with various QMS software, especially Greenlight Guru, Master Control preferred.

A willingness and ability to wear multiple hats, operate independently, and as part of a team in a small organization setting where a self-starter personality is key.