Mfg/Ops Quality Engineer 1
Target Pay Rate: 29.75–37.25/hr **salary will be commensurate with experience
Execute to quality system controls in SAP.
Assist with release of raw material, component and final product through system controls in SAP.
Develop, deliver, and drive global QMS projects (transition, due diligence, integration) to ensure compliance to applicable regulations and standards.
Utilize best practice project management to ensure goals, objectives, and performance metrics are met and/or exceeded.
Assist in the definition of project scope and objectives, involving all relevant stakeholders and ensuring technical feasibility.
Establish and maintain cross-site communication channels with Quality department stakeholders to assure Quality department alignment.
Engage 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 key Quality decisions, processes, and ERP (and related) configurations.
Advises 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 preferred.
Knowledge 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 skills.
\Adaptable to fast-paced, dynamic work environment with shifting demands. Listed 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.
Recommended Jobs
Director, Product Design
The global Red Bull Digital Products & Services technology team is responsible for building, launching, and maintaining cutting edge technology solutions to support all global consumer-facing digital…
Full Time Occupational Medicine Job Red Bluff, CA
Come practice in Red Bluff, a city in and the county seat of Tehama County, California. It is located 131 miles north of Sacramento and 31 miles south of Redding, on the banks of the Sacramento River …
Software Test Lead
Job Description Job Description IESE Solutions is seeking a Software Test Lead to support to the US Space Force (USSF) in developing and deploying novel command and control applications within …
Route Service Representative (4 Day Workweek)
Requisition Number: 207133 Job Description Cintas is seeking a Route Service Representative to manage and grow customer accounts in the Rental Division. Our partners drive a truck along an est…
Managing Partner, IT Strategy Consulting, State & Local Government, ERP or Medicaid
Description Who we are: Gartner’s Consulting business is an extension of Gartner’s industry-leading IT Research. From CIOs, to leaders in business and government, we help Gartner clients acr…
Operations Team Manager
Tiffany & Co. seeks an Operations Team Manager in Costa Mesa to lead and support sales, operations, and merchandise teams. This role involves ensuring inventory levels, driving client relationships, a…
Med/Surg | RN
Travel Med/Surg Registered Nurse (RN) Job – Nashville, TN Advance your nursing career with a rewarding Travel Med/Surg Registered Nurse (RN) assignment in Nashville, Tennessee (37203). Join a top-r…
Material Handler 1
Roles & Responsibilities Maintain inventory records and investigate discrepancies. Conduct cycle counts and resolve material variances. Provide materials for manufacturing as directed. Im…
Emergency Medicine Advanced Practice Clinician in Stockton, CA
TeamHealth has an excellent full-time opportunity for a physician assistant (PA) or nurse practitioner (NP) to join our emergency department (ED) team at St. Joseph's Medical Center in Stockton, Cali…
Lead Product Manager - Card Growth
Innovate with purpose At BILL, we believe in empowering the businesses that drive our economy. By replacing outdated financial processes with innovative tools, we help businesses—from startups t…