Design Quality Manager – Medical Device
Are you looking for a growth opportunity? A Global Leader in the manufacturing of Medical Devices is expanding and in need of another leader on their Quality team. With a global presence, a deep pipeline, and industry leading manufacturing facilities they are a stable organization positioned for growth.
The Design Quality Manager will serve as the focal point to support the globalization of business through leading and coordinating the standardization of systems, procedures and policies across all work cells within a growing global business. So we need a “doer” who is motivated and proactive. This broadly defined assignment will lead a team of Design Quality Engineers and represent Quality in Design Review meetings, so you must have in depth design experience (from concept to Design). You will also ensure that current and future quality and manufacturing systems meet and or exceed stakeholder and regulatory requirements. Other responsibilities are to provide leadership/mentoring and technical assistance to direct reports and site Quality Managers and Staff.
Tactical duties include creating, gathering, and entering the complete design package data into the companies PDM system for ECO release and providing technical support for all manufacturing builds including engineering prototypes, NPI, and production releases.
We are looking for a Design/Quality Professional who has the bandwidth to move into the Director of Quality role within 18-24 months.
The successful candidate MUST have the following qualities:
- At least 5 years’ experience in Design Engineering including Supervisory/Management experience (Mechanical or Electrical Design).
- Experience in Medical Device Quality
- 5+ years of relevant Quality experience.
- A Bachelor’s Degree in Engineering.
- Experienced with ISO standards 21 CFR 820; 13485 & 14971.
- Well versed utilizing KPI’s and metrics in a quality environment.
- Experience with DFMEA, SPC, and Control Plans.
The compensation plan includes an above-average base salary, an excellent bonus program and expanded benefits. Relocation is also available.
If you are a motivated, self-starter who would like to help this organisation grow, and if your background and qualifications meet these specifications, please respond.
Please E-mail your confidential resume in Microsoft Word.
YOUR PRIVACY AND CONFIDENTIALITY ARE GUARANTEED.
NO TELEPHONE CALLS PLEASE. Due to the high volume of resumes received, only applicants with specific experience requested by our clients will be contacted.
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