3D Systems is a dynamic and leading enterprise, specialized in 3D Printing of metal and other material components. 3D Systems is not only a technology developer but also a technology user. This makes us a strong innovation partner for clients in the aerospace, industrial, medical and dental sectors. We are experts in digital workflows, patient-specific devices, and five different kinds of 3D printing. The Quality department serves both the Virtual Surgical Planning as well as the Contract Manufacturing product lines with plastic and metal additive manufacturing.
The 3D Systems site in Littleton, Colorado is expanding and needs a skilled Quality Engineering Manager reporting directly to the Director of Global Quality to lead a team of quality professionals, including engineers, specialists, inspectors, and others, to support products developed and owned by 3D Systems, as well as customer-designed products where 3D Systems is the contract manufacturer. You will use your knowledge of quality engineering, risk management, project management, and lean six sigma to positively influence production and post-production activities to achieve high customer satisfaction.
Responsibilities for the team that the Quality Engineering Manager will lead may include the following and other duties may be assigned.
Provide oversight for the development and maintenance of quality programs, systems, processes and procedures that conform to established internal and external standards and guidelines.
Provide leadership in the continual improvement of the Quality system.
Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to ensure compliance.
Participate in the transfer of new projects into manufacturing and continue providing quality engineering support until product obsolescence.
Responsible for inspection and quality control activities to meet quality and operational goals.
Make use of appropriate quality tools, such as DOE, SPC, hypothesis testing, and capability studies to measure, monitor, improve processes.
Lead the investigation of complex product problems. Identify and manage corrective actions resulting from problem investigations.
Lead the response to customer inquiries and escalations for product issues experienced by customers.
Responsible for the management of suppliers with accountability to support selection, approval and qualification of new suppliers or changes to existing supplied products and processes, as well as oversight of performance and improvement activities.
Collaborate with process owners to establish training of personnel accordingly.
Develop and monitor appropriate quality metrics for review by management including inputs into the management review process.
Utilize computer and software programs and database management.
Assist during internal and external audits.
Review and provide feedback on Quality Agreements with customers.
Select, develop and evaluate personnel to proper allocation of quality engineering tasks.
Assist quality management in setting the strategy for the Global Quality organization.
Lead post-market surveillance, commercial holds, complaint handling, post market risk assessment, product field action assessment, post-market design changes, and NC/CAPA investigations.
Education and Training
8 years of related work experience in regulated, cGMP environment such as medical device, pharmaceutical or aerospace.
3 years of direct management/supervisory experience required
Certifications including but not limited to: Quality Engineer, Reliability Engineer, Manager of Quality and Operational Excellence, Quality Auditor, and/or Six Sigma Black Belt from ASQ or other equivalent.
Knowledge, Skills & Abilities
Expert knowledge and practical experience in the use of Medical Device regulations (CFR 820.30, ISO 13485:2016 / EU MDR; etc;) and best practices.
Skilled in statistical methods (Hypothesis testing, SPC, sampling plans, Gage R&R, process capability and graphical analysis).
Able to analyze and chart data using MS Excel or Minitab.
Good understanding on inspection methods and procedures.
Strong Knowledge in Lean Manufacturing / Six Sigma methodologies.
Experience with design of experiments (DOE), failure mode and effects analysis (dFMEA and pFMEA) and control/monitoring plans.
Demonstrate ability in selecting, interviewing, training, coaching, motivate, discipline, and direct people.
Self-motivated, able to manage a diverse team, able to accomplish multiple assignments simultaneously.
Strong project management, organizational, and problem-solving skills.
Ability to establish team goals and coordinate a wide variety of resources to meet quality metrics
Excellent computer skills.
Ability to communicate effectively, both verbally and in writing, with a wide variety of internal and external customers.
Compensation and Benefits
Salary Range: $102,600 - $153,900 (salary to be determined by the education, experience, knowledge, skills, and abilities of the candidate, and alignment with market data).
In addition to a salary, this position is eligible for an annual bonus based upon company performance.
3D Systems offers a comprehensive benefit package including medical, dental and vision coverage, company-paid short-term and long-term disability insurance, and company-paid basic life insurance. Sick Leave, Flex (Vacation) Time, Parental Leave, and paid time off for recognized holidays. 3D Systems also provides a 401(k) Retirement Savings Plan option with a company match.