Director of Quality Assurance

Position Description

This leadership role will create and implement the business direction for all Quality Assurance programs at Pirouette Medical. Provides guidance and expertise in areas related to all quality assurance programs. Introduces and leads efforts for improving product quality and driving the culture of quality. Oversees the compliance of the Quality Management System (QMS) to industry Standards and FDA requirements specific to the markets where the product(s) will be commercialized. Implements the overall supply chain strategy by leading supplier qualifications, audits, ongoing monitoring, and ongoing supplier continuous improvement action plans.

Essential Duties

• 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.

Skills and Abilities

• Ability to independently develop and implement processes and procedures as well as manage the day-to-day quality activities and ensure the QMS (complaint handling, incoming QA inspection, document control processing, monitoring dashboards, etc.) is adequate.

• Demonstrated experience with continuous improvement philosophy that has resulted in significant gains.

• Ability to oversee the Quality Training Program ensuring that Pirouette and supplier/CMO employees are trained and adhere to SOPs, work instructions and safety requirements.

• Ability to collaborate with other functional teams to identify, investigate, and resolve product quality issues including establish service level agreements for response and corrective actions.

• Ability to use statistical tools to analyze data, make acceptance decisions, and improve process capability.

• Ability to travel both domestically and internationally.

Required Education and Experience

• 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.

Location

Portsmouth, NH preferred, remote acceptable. Travel is expected from time to time for in-person meetings and travel to suppliers/CMOs to monitor and validate compliance as well as to coordinate audits by Pirouette, other suppliers/CMOs, and regulatory bodies (e.g., FDA).