Kelly Services Quality Engineer in Raynham, Massachusetts
Quality Engineer in Raynham, MA
Kelly Services is currently seeking a Quality Engineer for one of our top clients in Raynham, MA.
The Quality Engineer conducts assignments encompassing complete projects or portions of major projects.
They determine methods and techniques to be used or adapt standard methods to meet variations.
They coordinate phases of work internally and externally.
The Quality Engineer will utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle.
The incumbent will also utilize Quality Engineering principles and problem solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision.
He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes.
This person will support processes in base business.
Major Responsibilities Duties:
Business Improvements Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
Conduct benchmarking to develop more effective methods for improving quality
Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.
Compliance/Regulatory Review/analyze whether current product and processes including actions or decisions conducted are in compliance to standards such as the QSRs, ISO 13485, etc.
Champions compliance to applicable Global Regulations and standards e.g. QSRs, ISO, EN and Medical Device Directive MDD requirements including providing support during internal and external audits.
Conduct periodic line audits to assess for production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate.
Product Quality, Control Disposition and Performance Standards Supports activities related to the Material Review Board.
Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints.
Escalation of quality issues as appropriate.
Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
Analyze/review effectiveness of preventive and corrective actions.
Review root cause investigation according to an established process.
Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality Product/Process Qualification
Approve IQ, OQ, PQ, TMV or Software Validation Production/Process Controls including Control Plans Partners with Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed.
Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk. Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
Develop, interpret and implement standard and non-standard sampling plans
Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.
Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits.
Risk Mitigation Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs
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.
As a Kelly Services employee, you will have access to numerous perks, including:
Exposure to a variety of career opportunities as a result of our expansive network of client companies
Career guides, information and tools to help you successfully position yourself throughout every stage of your career
Access to more than 3,000 online training courses through our Kelly Learning Center
Weekly pay and service bonus plans
Group-rate insurance options available immediately upon hire*
*Available for purchase and administered by a designated third-party vendor
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.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm