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CAPA Leader

Westford, MA 01886, USA Req #423
Tuesday, October 5, 2021

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

Cynosure is seeking an experienced CAPA Leader who has a Passion for continuous improvement to join our Quality team. Reporting to the Quality Assurance Manager, the CAPA Leader will lead the execution and performance of the Corrective and Preventive Action Quality Management System (QMS) activities. This includes establishing the process, implementing and mentoring, and being the subject matter expert for the process during inspections. The Leader will provide clear guidance for this area to the organization by ensuring clear policies, procedures, instructions, forms, and objectives are provided. This role can be based in Westford, MA or Remote US.


Essential Duties and Responsibilities
Responsibilities:

  • Ensure compliance to internal QMS requirements, ISO 13485 or 21CFR820 as applicable.
  • Ensure controls, measurements, and metrics for CAPA process to demonstrate the level of effectiveness of the process.
  • Form strong partnerships with cross functional teams and leaders.
  • Lead the CAPA process, establish best practices, drive process and quality improvements.
  • Train internal employees on CAPA Process, regulations and necessary activities.

Additional Responsibilities:

  • Support the Quality Department objectives and goals by managing or participating in Quality projects / CAPAs
  • Act as a liaison between Quality and other Cynosure departments
  • Participate in Quality Management Review meetings
  • Lead CAPA Review Board meetings and drive CAPA quality and timeliness.

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


Qualifications
 

Education

Associate’s degree required

Bachelor’s degree required

Master’s degree required

PhD required

Education and experience combination:

Associate’s degree is equivalent to 18 months of experience

Bachelor’s degree is equivalent to three (3) years of experience

Master’s degree is equivalent to four (4) years of experience

Specific Area of Study: N/A


Experience

5 to 8 years relevant experience

Specific Related Experience: QMS, CAPA, Analytics 


Skills

  • Experience in developing metrics, completing root cause analysis/investigation
  • Ability to effectively interface and communicate with multiple internal and external constituents, including senior management, customers, consultants, vendors, and employees of all level
  • Ability to build relationships and work collaboratively with peers and team members
  • Change agent who accepts and supports new ideas and processes
  • Strongly demonstrated written and verbal communication and presentation skills
  • Effective time management / multitasking skills
  • Ability to consistently balance sense of urgency with diplomacy/empathy
  • Ability to make decisions and execute directives
  • Strongly demonstrated attention to detail
  • Strongly demonstrated organizational and project management skills
  • Demonstrated proficiency with common Microsoft office programs (Word, Excel, PowerPoint, Project, Visio)
  • Ability to work under tight deadlines and handle multiple detail-oriented projects
  • Ability to work autonomously and provide guidance to CAPA owners

Embody and deliver the “Exceptional Everyday”


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.
  • Safety Shoes compliant with site specific policies/procedures must be worn in designated areas
  • Potential Exposure to blood.
  • Other (please specify)

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

Other details

  • Job Family Quality
  • Job Function Quality Engineering
  • Pay Type Salary
Location on Google Maps
  • Westford, MA 01886, USA