inSync Staffing
Quality Engineer
inSync Staffing, San Diego, California, United States, 92101
Quality Engineer 1$30.00-$37.25/hr8am-5pm Mon-FriOnsite: San Diego, CA - Hybrid - onsite 3 days per week4 month+ assignment
JOB DESCRIPTION
Responsibilities:Develop global governance of quality system controls in SAP Establish and/or improve system controls in SAP for release of raw material, component and final productDevelop, deliver, and drive global QMS projects (transition, due diligence, integration) to ensure compliance to applicable regulations and standardsUtilize best practice project management to ensure goals, objectives, and performance metrics are met and/or exceededAssist in the definition of project scope and objectives, involving all relevant stakeholders and ensuring technical feasibilityEstablish and maintain cross-site communication channels with Quality department stakeholders to assure Quality department alignmentEngage SMEs to Validate (i.e. vet with SMEs, stakeholders, and key site Quality personnel) all Quality department ERP requirements before configuration Host design reviews, specifically addressing keyQuality decisions, processes, and ERP (and related) configurationsAdvises and consults on QMS project/quality plans, risk assessments and remediation plans Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Requirements:0-2 years experience in quality assurance field in a regulated environment; direct experience working in in-vitro diagnostic manufacturing preferredKnowledge and experience applying quality regulations and standards (21CFR 820, ISO 13485, ISO 14971, IVDD)Knowledge and experience with instituting quality controls in an ERP system, SAP preferred Highly effective communication, facilitation and negotiation skillsAdaptable to fast-paced, dynamic work environment with shifting demandsListed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position.Changes to individual responsibilities may occur due to business needs.
Benefits:(employee contribution)? Health insurance? Health savings account? Dental insurance? Vision insurance? Flexible spending accounts? Life insurance? Retirement plan
All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
JOB DESCRIPTION
Responsibilities:Develop global governance of quality system controls in SAP Establish and/or improve system controls in SAP for release of raw material, component and final productDevelop, deliver, and drive global QMS projects (transition, due diligence, integration) to ensure compliance to applicable regulations and standardsUtilize best practice project management to ensure goals, objectives, and performance metrics are met and/or exceededAssist in the definition of project scope and objectives, involving all relevant stakeholders and ensuring technical feasibilityEstablish and maintain cross-site communication channels with Quality department stakeholders to assure Quality department alignmentEngage SMEs to Validate (i.e. vet with SMEs, stakeholders, and key site Quality personnel) all Quality department ERP requirements before configuration Host design reviews, specifically addressing keyQuality decisions, processes, and ERP (and related) configurationsAdvises and consults on QMS project/quality plans, risk assessments and remediation plans Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Requirements:0-2 years experience in quality assurance field in a regulated environment; direct experience working in in-vitro diagnostic manufacturing preferredKnowledge and experience applying quality regulations and standards (21CFR 820, ISO 13485, ISO 14971, IVDD)Knowledge and experience with instituting quality controls in an ERP system, SAP preferred Highly effective communication, facilitation and negotiation skillsAdaptable to fast-paced, dynamic work environment with shifting demandsListed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position.Changes to individual responsibilities may occur due to business needs.
Benefits:(employee contribution)? Health insurance? Health savings account? Dental insurance? Vision insurance? Flexible spending accounts? Life insurance? Retirement plan
All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.