Principal Product Quality Engineer

Cynosure, LLC.; Westford (MA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Travel up to 25%

Equal Opportunity Employer

Job summary

Cynosure, LLC. in Massachusetts is seeking a qualified Quality Engineer to oversee product quality, transfer to contract manufacturers, and drive continuous improvement within a FDA/ISO 13485 environment.

You will lead QC activities, support CAPAs, and collaborate with suppliers and manufacturing to ensure compliance and robust quality systems. The role emphasizes interpreting quality data, defining action plans, and maintaining documentation, SOPs, and risk management files.

Qualifications

• Bachelor's degree in Engineering is required.
• 5–8 years of experience in quality, product development, or process development within FDA/ISO 13485 medical devices.
• ASQ CQE or CQA certification is desirable.
• Experience with capital equipment and sterile products is a plus.

Responsibilities

• Support the local QMS with QE support and root cause analysis.
• Coordinate inspections with contract manufacturers and define in-line inspection points.
• Develop and implement KPIs for the QC team and drive improvements.
• Own CAPAs and participate in cross-functional teams to meet quality goals.

Skills

Root cause analysis

QC experience

Communication skills

Statistical analysis

Process improvement

Documentation skills

Education

BS in Engineering

CQE certification

CQA certification

Tools

Minitab

ERP systems

MS Excel

Document control software

Job description

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.

Learn more about us by following our LinkedIn and Instagram sites and please visit us at www.Cynosure.com.

Job Summary

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.

Essential Duties And Responsibilities

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 company goals. Lead product quality related meetings; follow-up with team members for updates and actions; and distribute meeting minutes.
• Support Quality Control inspection group to ensure product quality is present at incoming, in-process, and at final inspection. Establish inspection procedures and provide guidance in inspection methodology. Provide technical oversight to the QC group.
• Prepare and update Quality Assurance documents and SOPs. Review and approve interdepartmental records, documents and SOPs to ensure conformance with the regulations and guidelines.
• Support special project team activities; complaint or CAPA investigations; and product or process risk analyses as needed.
• Must be team player, willing to contribute and collaborate to drive departmental goals
• Embody and deliver the “Exceptional Everyday”

Qualifications

Education

Bachelor’s degree required

Specific Area of Study: BS in Electrical, Mechanical or Optical Engineering preferred

Experience

5 to 8 years relevant experience

Specific Related Experience: Experience in quality, product development or process development within FDA and/or ISO 13485 regulated medical device setting, with hands on knowledge of regulations. Experience in medical devices manufacturing; experience with software driven electro-mechanical medical devices highly preferred. ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) certification desired. Previous experience supporting capital equipment and sterile products

Skills

• Ability to read, analyze and interpret international and national Quality standards.
• Ability to effectively communicate and present information to top management and auditors from various compliance agencies.
• Ability to communicate efficiently and effectively with all levels within Quality as well as cross functionally with departments such as Manufacturing, Engineering and Purchasing.
• Proficient in the areas of statistical principles and applications; qualitative and quantitative data analysis; DOE, Acceptance and Sampling; process improvement/optimization; gage R&R measuring systems; and system and product audit.
• Proficient in manufacturing and quality documentation development
• Ability to work independently or under minimal supervision
• Understanding of manufacturing processes, challenges, and solutions
• Knowledge of Microsoft Word and Microsoft Excel
• Working knowledge of statistical programs (Minitab or other statistical packages)
• Knowledge of ISO standards for Class II medical devices preferable (ISO 13485, 14971)
• Working knowledge of electronic quality management systems and/or manufacturing execution (ERP) systems
• Exceptional analytical, electronics and electromechanical aptitude, problem solving, and root-cause analysis skills
• Excellent organizational skills
• Strong written and verbal communication skills

Physical Demands

• Sit; use hands to finger, handle or feel objects, tools, or controls.
• Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.
• Other (please specify) travel up to 25% to contract manufacturers and suppliers in MA.

Cynosure is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran