Sr. Product Quality Engineer job vacancy in Bioethic Consulting – Jobs in California
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Company Name : Bioethic Consulting
Company Location : Alameda, CA
Job Position : Sr. Product Quality Engineer
Job Category : Jobs in California
Job Description :
A Medical Device client in Alameda, CA is currently looking for a to work on a Sr. Product Quality Engineer 12-24 months contract with the possibility of extension/Direct hire. The selected person will be working an 8 am- 5 pm Monday to Friday work schedule.
Supports multiple Quality process improvement initiatives and provides Lean Six Sigma Project support for high-impact business improvements. Responsible for quality-related activities to deliver consistent; high quality documents; services; products and processes.
Supports multiple continuous improvement initiatives and may lead or support Kaizen
Key contributor to the development and execution of streamlined business systems
which effectively identify and resolve quality issues- Apply sound, systematic problem-
solving methodologies in identifying, prioritizing, communicating, and resolving quality
Evaluate the value and impact of both ongoing and completed quality improvement
Establish and present quality performance metrics which drive accountability and
delivery of targets
Identify, propose and implement quality management procedures and processes to
drive the interrogation of relevant data, trend analysis and to continuously improve the
quality management and system assurance function
Support the Quality Assurance review and approval of complex change controls,
deviations/investigations, CAPAs, quality engineering, and continuous improvement to
ensure that they meet the requirements of applicable standards and procedures, and
are clearly and appropriately justified
Solve challenges related to customer complaints- Lead and drive the investigation,
resolution and prevention of product and process nonconformance’s
Supports Implementation of procedures, training and systems and ensure product
complaints process for all new products is in place to support their launch and lifecycle
management – Maintains and continuously improves highly effective procedures related
to complaint processing and complaint investigation
Bachelor’s degree in Science, Engineering or a closely related discipline. With Minimum
4 years of relevant working experience
Six Sigma Black Belt (CSSBB) or ASQ Certified Quality Engineer (CQE) is highly desired
Engineering experience and demonstrated use of Quality tools/methodologies
Knowledge of FDA, GMP, ISO 13485, and ISO 14971.
Solid communication and interpersonal skills
Strong project management and leadership skills
Advanced computer skills, including statistical/data analysis and report writing skills is a
Medical Devices/Diagnostics and/or other regulated healthcare industry experience is
Experience implementing various product and process improvement methodologies
(e.g., Value Stream Mapping, Six-Sigma (DMAIC), Lean, Kaizen)
Experience working in a broader enterprise/cross-division business unit model
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast-paced, changing
Ability to leverage and/or engage others to accomplish projects.
Strong verbal and written communications with ability to effectively communicate at
multiple levels in the organization.
Multitasks, prioritizes and meets deadlines in timely manner.
Strong organizational and follow-up skills, as well as attention to detail.
Demonstrates analytical capability to find systemic issues to root cause, and create actions plans to mitigate, close and/or eliminate.
Knowledge in software and hardware development life cycle
Job Types: Full-time, Contract
- 401(k) matching
- Health insurance
- 8 hour shift
- Day shift
- Monday to Friday
Ability to commute/relocate:
- Alameda, CA: Reliably commute or planning to relocate before starting work (Preferred)
- Bachelor’s (Preferred)
- Medical Device Industry: 2 years (Preferred)
- FDA regulations: 2 years (Preferred)
- Six Sigma Black Belt(CSSBB) or ASQ Certified: 2 years (Preferred)
Work Location: One location
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