Quality Control Lead

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 perform quality activities in support of new and existing products as well as performs a wide variety of activities to ensure part and product compliance with applicable specifications, including Incoming Inspection, In-process Inspection, Final Inspection, DHR Review, Depot Inspection. The position interacts with many internal departments including Engineering, Manufacturing, Materials, Quality Assurance, and Customer/Field Service.

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.

• Perform required inspections, measurements, and testing of incoming parts, field service replaceable units, in-process assemblies, and finished products per established criteria; record results on appropriate documentation; and communicate any discrepancies to the person(s) responsible for corrective/preventive action activity.
• Perform inspections as requested for Engineering and other departments. (First Articles and/or courtesy inspections) and assist with the development of applicable inspection procedures, checklist, forms, and Inspection Folders.
• Regular use of ERP and PLM systems such as Oracle, SAP, Dayforce, or others
• Use Microsoft Office to ensure full documentation of activities.
• Perform Incoming / In-Process Inspection on mechanical / electrical components using standard inspection equipment such as Height Gauges, Surface Plates, Verniers, Dial Indicators, Ring / Plug Gauges, Optical Comparators, CMM ECT.
• Document discrepancies or defects and issue Non-Conforming Material Reports (NCMRs).
• Create NCMRs in SAP as needed
• Support calibration coordinator with facilitating calibration of gages by third parties
• Maintain control of non-conforming product in accordance with documented procedures, ensure product identification and traceability at all times, and assist with control of measuring and test equipment calibration.
• Provide leadership to production personnel on quality issues.
• Comply with and reinforce the requirements of Cynosure's Quality Management System, Standard Operating Procedures, ISO 13485:2016, FDA Quality System Regulations, and other applicable regulations.
• Performs job duties with minimal supervision or assistance.
• Embody and deliver the "Exceptional Everyday" mentality.

Qualifications:

Education

☒High School degree/equivalent required

Experience

☒2 to 4 years relevant experience

Specific Related Experience: as a QC inspector in a regulated industry; medical device manufacturing under ISO 13485:2016 highly preferred. Certified Mechanical Inspector (CMI) or equivalent quality technician training / experience desired. Experience interpreting technical drawings and specifications.

Skills

• Knowledge using ERP and PLM systems, preferably SAP, Oracle, or Agile
• Proficient with measuring equipment such as Height Gauges, Surface Plates, Verniers, Dial Indicators, Ring / Plug Gauges, Optical Comparators, CMM ECT
• Proficiency in the use of measuring and test equipment
• Ability to perform mechanical inspection set-ups independently
• Very high level of attention to detail
• Good record-keeping, documentation skills, and computer skills
• Excellent communication skills, both verbally and written
• Experienced in the use of PCs and Microsoft Office software applications
• Medical device, aerospace, automotive, or other regulated manufacturing environment preferred

Physical Demands

The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• ☒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.
• ☒Lifting/pushing/pulling and carrying products weighing up to 45 pounds
• ☒Potential Exposure to moving mechanical parts, vibration and/or moderate noise levels.
• ☒Potential Exposure to hazardous chemicals or other materials.

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