Quality Engineer - Fremont, CA

Fremont  ‐ Onsite
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Keywords

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
Start date
01/2014
From
Real Staffing
Published at
24.01.2014
Project ID:
655137
Contract type
Freelance
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