Principal Product Quality Engineer

Cynosure Inc, 5 Carlisle Rd, Westford, Massachusetts, United States of America

Cynosure is well positioned competitively to lead and transform the medical aesthetics industry. We are guided by our belief that this is a purpose-driven business, which improves patient’s lives and improves practitioner’s livelihoods.

• We are passionate about driving a healthy and growing medical aesthetics industry with leading-edge marketing which inspires consumers to engage in medical aesthetics.
• We are the leader in science-based technology which elevates the standard of care for consumers.
• We are relentlessly focused on being the undisputed innovation leader, addressing the growing demand for consumer treatments across all demographics.
• We are committed to building and strengthening our unmatched global footprint, with direct employees on five continents and in 15 countries and growing, and distributor partners serving over 130 countries.
• We put our people first and believe personal development drives business development.
• We love our customers and strive give them the leading-edge technology, service, marketing support and clinical education to improve their patient’s outcomes and to improve their livelihoods.

At Cynosure, we look for people who make an impact and encourage everyone to lead, create, and add value. In turn, we invest in our team to grow people’s careers and build upon our high-performance and culture-oriented organization. We work together as one team, winning together.

As we grow our global team, there is no better time to join us. As a market leader in medical aesthetics, Cynosure has over 25 years developing, manufacturing, and marketing products for dermatologists, plastic surgeons, medical spas, and healthcare practitioners. With the aesthetic industry’s most comprehensive product portfolio, our offerings span several categories including skin revitalization, body contouring, hair removal, and women’s health.

Our mission is to set Cynosure customers up for success shaping future leaders of the aesthetics industry and helping everyone who uses our technologies discover their version of beautiful.

Responsible to ensure all aspects of overall product quality with strong focus on overseeing product transfers to contract manufacturers and continuous product/process quality improvement with Cynosure suppliers makes improvements to the company quality system. Oversight on local QC team. High visibility role in the organization.

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

• Support the local QMS with QE support. Interpret quality data and non-conformances. Perform failure evaluations, determine root cause, and implement corrective action.
• Work closely with contract manufacturers on product transfers and process validations, help define in line inspection points to improve product quality, author product quality plans as needed.
• Work with suppliers and contract mfgs to drive root cause investigation and appropriate corrective actions.
• Manage Quality Control team including QC Inspectors, Doc Control Quality Analyst, Calibration Coordinator.
• Coordinate inspection activities to meet production and contract manufacturer requirements. Provide inspection guidance on inspection methodology.
• Work collaboratively with Operations on issue identification, escalation, root cause investigation, and corrective actions.
• Develop and implement KPIs for QC team to measure operational performance.
• Oversight on QC processes, including Incoming Inspection, In-process Inspection, Final QC, DHR Review, Calibration SOP. Drive updates and improvements to current processes.
• Own and manage individual CAPAs. Work with cross functional team to investigate root case and drive corrective actions.
• Support risk management activities. Able to update risk management files and draft Health Hazard Evaluations as needed.
• Support the MRB evaluation process. Represent QA on cross-function MRB committee.
• Initiate and/or participate in cross-functional teams to support department and…