Staff Quality Engineer III (Passaic)
Compensation: $96,150.00 - $135,490.00 /year *
Employment Type: Full-Time
Kelly Services currently has an opportunity for a Staff Quality Engineer to work at a prestigious Medical Device development company located in Somerset, NJ
Duration: 14 Months+
Remote position; however, must be local to Somerset, NJ
Pay Range: $42 - $48/Hour
The Staff Quality Engineer is responsible for the implementation and supervision of Quality and Compliance programs at facilities within the DELIVER NA MD Region that distribute orthopedic loaner sets to healthcare providers. These facilities include Forward Stocking Locations (FSL) which are managed by Third Party Logistics providers (3PL) and/or Field Inventory Locations (FIL) which are managed by DELIVER NA. This position serves as a liaison with Quality and Supply Chain partners, and the DELIVER NA Leads on Distribution Quality related matters and collaborates with the company's Franchise Quality and DELIVER NA organizations to drive timely resolution of Quality related issues. This position identifies opportunities to continuously improve quality and compliance consistent with DELIVER NA business objectives.
The Staff Quality Engineer supports proposals and quality and compliance programs designed to ensure effective and consistent processes with established standards by performing the following duties personally or through work stream groups.
Design and execute a Quality System for the Forward Stocking Locations (FSL) and/or Field Inventory Locations (FIL).
Prepare, facilitate and conduct/support Internal Quality Audits of the FILs including monitoring of trends, identification of issues and recommendation and implementation of appropriate actions, when applicable.
Facilitate, coordinate and assist in Supplier Audits associated with the FSL, when applicable.
Support all internal (JJRC) and external Health Authority inspections (e.g. VAWD, FDA, TUV/BSI) and any other logistics and transportation related inspections (e.g., TSA) conducted at network sites.
Ensure the Quality program maintains regulatory compliance.
Support execution of the Quality System for assigned facilities and across network.
Support cross-functional teams to identify and correct distribution related issues.
Coordinate and assist in maintaining current state licensure and registrations for assigned sites, as required.
Oversight of Quarantine/Hold/Stop-Ship/Recall processes for assigned sites.
Support the Loaner Kit processing, including trending of errors.
Management of the inventory processing, including kit/lot reconciliation within the FIL/FSL/3PLs.
Ensure returned product is dispositioned according to predefined agreements with Operating Company, Franchise, or Marketing Company.
Provide quality support for technology transfer and improvement of existing distribution processes.
Assist in the development, implementation and review of standard operating procedures for interactions with contract distribution providers.
Develop or enhance systems/processes in the following areas: execution of the change control process, monitor the Calibration and Preventive Maintenance systems (as applicable, trending of service-related complaints and make proposals and assist in the development of corrective action plans and monitor implementation including follow-up on closure and metric reporting of CAPA, NC, and audit observations, as applicable), and establish and maintain relationships with NA DELIVER and Franchise customers in order to solve problems and meet changing competitive and regulatory environments.
Important information : This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Please apply online or contact ...@kellyservices.com for immediate consideration
Why Kelly ? Kelly puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm with an unmatched reputation for quality, integrity, and professionalism. Whether you seek the variety and flexibility of working on short-term project engagements or prefer contract-to-hire or direct-hire placement with our clients, apply with Kelly to explore opportunities that suit your specific professional interests. About Kelly At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.
Associated topics: business, cost efficient, industrial engineer, manufacturing engineer, methods engineer, project, sap, supply, supply chain
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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