Sr. Quality Engineer
- Job type: Contract
- Salary: competitive
- Location: Palo Alto
- Reference: RE-32496450
Senior Quality Engineer | Contract
Location: Palo Alto, CA
Industry: Medical Device
Real Life Sciences has an exciting opportunity for a Senior Quality Engineer for our client who has created an innovative and exciting women's health device.
The quality team is seeking a Senior Quality Engineer who will be responsible for providing quality engineering leadership in support of design and manufacturing of an electro-mechanical product. This position will work closely with Operations and R&D on new product activities and support production and continuous quality improvement.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Responsibilities will include:
* Support manufacturing quality, including but not limited to:
◦Work closely with Operations to resolve in-house and supplier quality problems using established problem solving methodologies (Root Cause Analysis, Mistake-Proofing, etc.).
◦Review/approve product and process change control documentation and specifications.
◦Review/approve manufacturing and inspection tool design, automation systems and related system documentation.
◦Have an active role or lead the development, review and approval of process and equipment validation/qualifications (IQ, OQ & PQ).
◦Participate or lead supplier audits.
◦Initiate, investigate, review and approve nonconforming material and related system documentation.
* Write protocols and reports, and perform statistical analysis of data - when needed.
* Work with manufacturing and quality function to establish process control and manufacturing metrics and report regularly.
* Interface with suppliers for new processes, quality issues and process improvements for assigned projects.
* Minimum of 3-5 years of experience as a QE/Sr. QE
* Medical Device specific experience is required
* Experience working cross functionally with teams to complete engineering projects to assist in streamlining production
* Experience with production and process control, design control, process/test method validation, and root cause analysis
* Experience leading/driving projects is a plus
* Attention to detail
* Be an advocate for product excellence and quality
* Bachelor's degree in engineering or related field or equivalent work experience required
* CQE, RAC, RAB, ASQ or other quality and regulatory certificates are a plus
Real was established in 1998 and currently has 250 specialist recruiters globally veering Healthcare IT, Pharmaceuticals, Biotechnology, and Medical Devices.
Our approach is simple, we focus on recognizing talent, valuing relationships and delivering expertise. Globally, Real places a specialist every 45 minutes.