Sr. Product Quality Engineer job vacancy in Bioethic Consulting – Jobs in California

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Job Details
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.

Summary
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.

Responsibilities
 Supports multiple continuous improvement initiatives and may lead or support Kaizen
events
 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
issues.
 Evaluate the value and impact of both ongoing and completed quality improvement
projects
 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

Qualifications
 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
plus
 Medical Devices/Diagnostics and/or other regulated healthcare industry experience is
required
 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
preferred.
 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
environment.
 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

Benefits:

• 401(k) matching
• Health insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to commute/relocate:

• Alameda, CA: Reliably commute or planning to relocate before starting work (Preferred)

Education:

• Bachelor’s (Preferred)

Experience:

• 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