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15 days old

Quality Engineer, Devens, MA

Kelly Services
Devens, MA 01434
**Quality Engineer, Devens, MA**


**6-month contract via Kelly Engineering**


This position is responsible for providing investigation technical support, supplier process improvement, and scientific expertise and compliance knowledge to fulfill BMS requirements to implement supplier changes. Applicant must comply with Corporate and HR Policies, Security Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.


+ Perform investigations, using Infinity system, for Supplier Complaints including but not limited to BMS and Suppliers processes.

+ Create and execute Corrective Actions and Preventive Actions (CAPA)

+ Prepares, submit and discuss finding of the investigation process with key stakeholders.

+ Perform trending analysis of site events and complaints. Investigate and root-cause no-fault found investigations and implement internal process improvements to prevent reoccurrence.

+ Generates, reviews and implements procedure and forms to assure compliance with current practices or GMP trends.

+ Provides support to the supplier development team preparing quarterly data for Quality Council and governance meetings.

+ Evaluates and improves supplier complaint investigation and material return process.

+ Creates, evaluates, follows up and approves Change controls for the Devens site, including interaction with corporate support areas, other BMS sites and third parties.

+ Ensures Change controls are created according to local SOPs and corporate directives with all the appropriate requirements in placed for each change control, monitor and ensure actions are implemented and closed on time and status up-dated in related quality system. Inform supervisor or site procurement lead in case of issues.

+ Create detailed plans of the activities using Project Management tools.

+ Provides support, training and development to the suppliers and internaly to avoid BMS and Suppliers issues recurrence.

+ Implements processes and procedures to address supplier performance deficiencies.

+ Ensure compliance with corporate and site procedures, cGMPs regulations and other industry guidelines.

+ Apply Lean Six Sigma tools to reduce investigations establishing proper corrective, preventive and proactive actions.

+ Manages and executes supplier program for the investigation and resolution of deviations, CAPA, and complaints.

+ Provides oversight of suppliers preforming investigations, change controls, protocols and reports in support of BMS products.

+ Provide oversight of Investigations/CAPA management and tracking to ensure timely and compliant closure


**Education and Requirements**


+ Bachelors Degree in Business, Science or Industrial Engineering

+ Six (6) years of experience in Quality, Purchasing, or Manufacturing Technology (Technical Services) experience within a manufacturing pharmaceutical industry.

+ MS/MBA/CPIM/ASQ/Lean Manufacturing/Procurement experience is a plus.

+ At least 3 years handling investigations process

+ At least 3 years handling change control process

+ Must have proven track record of successfully managing projects, and responsible for developing & implementing quality processes in a pharmaceutical environment.

+ Strong customer service orientation with excellent analytic, interpersonal, communication and negotiating skills

+ Proactive, creative and analytic approach.

+ Strong understanding of supplier development & supplier quality experience is a must.

+ Short-term execution and long-term strategic thinking capabilities, ability to multitask with a sense of urgency.

+ Ability to interface with external resources and internal resources at all levels.

+ Demonstrated hands on supplier management implementation in FDA regulated businesses.

+ Ability to communicate effectively within a matrix organization.

+ Effective at selling ideas, services and solutions to others at different organizational levels and functions.

+ Demonstrates leadership, interpersonal, communication, and motivation skills

+ Excellent writing and oral communication skills are required


**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.


**Why Kelly?**


**Kelly Services is committed to employee inclusion through our dedication to foster an innovative workforce by recognizing, celebrating, and embracing the diversity that all Kelly employees bring to our organization and our customers.**


As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.


**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/non-traditional 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.


**\#KellyGTS**


**Why Kelly** **** **?**


Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.


**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 (plus, did we mention we provide a ton of benefits ?). 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2021-04-23 Expires: 2021-05-24

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Quality Engineer, Devens, MA

Kelly Services
Devens, MA 01434

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