Project Manager with CAPA (Medical Device) job vacancy in Syncreon Consulting, (Irvine, CA)

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We got a new job details in Syncreon Consulting & they are Hiring Candidates for Project Manager with CAPA (Medical Device)

Job Details
Company Name :
Syncreon Consulting
Company Location :
Irvine, CA
Job Position :
Project Manager with CAPA (Medical Device)
Job Category :
Jobs in California

Job Description :
Company Description
We work as trusted business partners and always strive to deliver the most value and highest return on investment for our clients. We are highly trained business professionals with strong understanding of clients need. We work closely with the leading staffing trade associations, training, and research organizations to ensure we are knowledgeable of the latest industry trends and technologies.

Job Description

Engineering, Technical, or Scientific discipline with minimum of 8-10 years of related experience is required, preferably within a regulated environment (e.g. FDA regulated).
Technical expertise in IQ / OQ / PQ processes at Mfg sites
Quality Engineering/Design or Process Excellence/Lean experience is preferred.
Collaborate to complete Component Qualification, document evidence.
Prepare Protocols, works requests & reports for Supplier Qualified components
Collaborate with suppliers to collect evidence and/or develop Production Part Approval Process (PPAP)
Knowledge of the QSR, Design Controls, and ISO quality requirements.
Experience conducting Process / Design Failure Mode Effects and Analysis
Focus on leading, managing, and developing the SQE team to achieve results
Experience in Performing and reviewing CAPA to investigate issues, identify root cause, and apply effective actions to prevent recurrence
Understand and interpret all manufacturing audits, including ISO 13485 and other industry standards.
Conduct supplier quality control audits on a regular basis to ensure vendors and their supplies remain in compliance with company and federal manufacturing and production standards.
Very Good in Oral & Written Communication
Train, mentor, and coach team members to share knowledge, build skills, and enhance talent development
Expertise in developing relationships with key stakeholders, navigate matrixed organization, recognize, and adjust to diverse cultures, and establish trust, credibility, and respect between both internal and external partners.
ASQ certifications are an asset

PH – 229-264-4029.

Additional Information
All your information will be kept confidential according to EEO guidelines.

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