This is a full-time and direct-hire position. This position is ONSITE in Marlborough, MA. No C2C or 3rd party or sponsorship currently. We appreciate all of our applicants, but we are not able to sponsor at this time.
A growing Medical Device Manufacturing company is hiring a talented and experienced Director Of Quality Engineering.
- Bachelor's degree in Engineering, Biology or Chemistry degree required.\t
- Minimum of 10 years of experience in a cGMP, ISO 13485, or ISO 9001 Quality Management System environment required.\t
- Minimum 8 years of experience mentoring and managing direct reports.\t
- Strong attention to detail.\t
- Enthusiastic, team player, collaborative across all departments to achieve the common goals.\t
- Lead auditor certified \t
- Experience with LEAN implementation strongly preferred.\t
- Demonstrated ability to foster a Quality Culture across the organization.\t
- FDA/regulatory experience; clean room operations, medical equipment and bio-pharm industries.\t
- Lean/Six Sigma Quality, statistical analysis, supplier quality assurance .\t
- Strong computer skills.\t
- Up to 10% travel to assist with external audit requirements
- Maintain compliance to ISO 9001:2015 for all aspects of the QMS including but not limited to Internal and External Auditing, Nonconforming Materials, Deviations, CAPA, Validation \t
- Partner with cross-functional stakeholders for continuous improvement activities, create/revise procedures/practices and specifications, and provide training on quality systems and procedures.\t
- Participate in continuous improvement activities by identifying and appropriately escalating process and product quality gaps, providing solutions when possible\t
- Represent Quality during New Product Development projects.\t
- Maintains, controls, verifies, and ensures ECO's are processed using Quality Documentation Management Systems.\t
- Represent Quality for all Product and Process Change Controls\t
- Develop, Monitor and Compile Quality metrics as inputs for Management review and Operation meetings with the Senior Management team.\t
- Build a robust Supplier Management Program \t
- Maintain internal and external (customer and vendor) audit schedules and develop and mentor auditor teams.\t
- Maintain strong cross functional quality focus: build, maintain and spread knowledge throughout organization\t
- Implement new risk-based strategy for overall Quality compliance across the organization and in support of the ISO 9001:2015 standard.\t
- Review and approval of validation plans, deviations, root cause and corrective action plans prior to implementation.\t
- Assists with OOS investigations, OOT investigations and NCMR investigations. \t
- Supervise direct report(s) which includes setting objectives, monitoring performance and conducting reviews
Kelly puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm with an unmatched reputation for quality, integrity, and professionalism. Whether you seek the variety and flexibility of working on short-term project engagements or prefer contract-to-hire or direct-hire placement with our clients, apply with Kelly to explore opportunities that suit your specific professional interests.
About Kelly ****
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm