QUALITY ENGINEER

We have created a Quality Engineer position working in our Malvern, PA headquarters. The Quality Engineer will report to the Director – Quality and Regulatory Affairs, and be responsible for collaborating with many different disciplines including Engineering, Supply Chain and Field Service to improve product quality and reliability and ensure compliance with quality standards. The ideal candidate will possess strong technical (electro-mechanical) knowledge, trouble-shooting (cause and effect) skills, a collaborative style and the ability to influence a quality mindset with business partners/suppliers.

This position offers the opportunity to work with a unique technology, in a fast-paced setting and have a significant impact on the business. There will be some travel in the position, primarily regionally to suppliers, but also some national travel working with field operations. We offer a competitive total compensation and benefits package.

Main Responsibilities:


  • Work with engineering to diagnose and development fixes for reliability issues experienced in the field and to improve overall reliability and quality of design. Act as the primary liaison between field service, engineering and supply chain on field failures.
  • Work with contract manufacturers and suppliers to improve the quality yielded from manufacturing processes through oversight and audit, refinement of manufacturing processes, implementation of engineering changes and other procedures.
  • Assure engineering design processes and manufacturing processes are efficient, are conducted in compliance with quality plan and ensure validation and testing protocols are robust. Instill an emphasis on design and test for reliability within the development activities. Ensure FDA and other regulatory requirements are met.
  • Support Manufacturing, Purchasing, and Development Engineering on the implementation and maintenance of a Supplier Quality Management Program.
  • Generate meaningful reports, utilizing statistical software as appropriate to evaluate trends and to aid management in the overall quality improvement effort.
  • Assure control and proper disposition of nonconforming products
  • Maintain Corrective & Preventive Action (CAPA) process and ensure timely follow-up, and implementation of corrective actions.
  • Conduct Internal Quality System Audits and assure corrective action is performed.
  • Assuring controlled documentation is current and correctly implemented.

Key Qualifications:


  • B.S. in Electrical Engineering or Mechanical Engineering strongly preferred. Equivalent work experience will be considered.
  • 10 plus year experience in some combination of Engineering and Quality roles, with at least two years in Quality function.
  • Experience with electro-mechanical equipment, preferably to include some industrial and some medical devices experience
  • Experience in ISO certified environment and a strong preference for knowledge of FDA regulations and GMP
  • Proven ability to deliver value in the following areas: supplier quality audits/improvement plans, reliability engineering, cause/effect or fault analysis and troubleshooting
  • Experience with statistical analysis software preferred and ability to synthesize data from various sources to identify trends is a must
  • Able to manage and report on projects and drive them to conclusion
  • Strong communication skills - able to challenge, influence, and articulate a view and drive behavior or action
  • Self-starter who works with a sense of urgency and acts as a good team player working with other disciplines
  • Adaptability and resourcefulness to roll-up-sleeves and multi-task in order to thrive in small company environment

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