Description
POSITION DESCRIPTION:- Ensure high level of compliance to FDA QSR/cGMPs and ISO 13485 in all assigned areas.
- Work closely with internal departments (Operations, Advanced Operations, R&D, and Distribution) to resolve in-house and supplier quality problems using established problem-solving methodologies (Root Cause Analysis, Mistake-proofing, etc.).
- Lead the resolution of quality issues related to non-conformance reports, cell shutdowns, customer complaints, regulatory actions, etc.
- Lead and/or support CAPA investigations and related corrective and preventive actions.
- Lead continuous improvement activities such as Quality Circles, Process Capability. Support Lean environment and re-work/scrap reduction.
- Participate in the development and improvement of manufacturing, distribution and/or other processes for existing and new products.
- Participate on project teams with internal departments to support product and/or process design and development activities.
- Develop, review and improve inspection plans, routers and product drawings.
- Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ).
- Interface with suppliers for new processes, quality issues and process improvements for assigned projects.
- Support product transfers to other plants/facilities.
- Lead or participate in implementation of Process Management activities (pFMEA and control plans) within assigned client groups.
- Review/approve product and/or process change control documentation and specifications.
- Participate in continuous (breakthrough) improvement activity and process re-engineering projects.
Orthobiologics only:
- Manage lower level projects and team initiatives.
- Operate within Stryker's quality system to produce/revise procedures and protocols related to the validation of packaging and/or labeling, and product stability.
- Execute product, package and/or label verification / stability testing per created protocols.
QUALIFICATIONS:
Bachelor's Degree in Engineering or related field of study or equivalent work experience. Prefer CQE certification and Six Sigma Green or Black Belt.
- 5+ years experience as a Quality Engineer (QE) in a regulated manufacturing environment. Prefer experience with validation responsibilities.
- Demonstrated applied knowledge of:
- FDA and international medical device regulations.
- Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, SPC, Root Cause Analysis, Mistake Proofing/Poka Yoke.
- Demonstrated ability to effectively work cross functionally with other departments including Operations, Product Development and Marketing.
To find out more about Real please visit www.realstaffing.com