4 days old

Quality Engineer

Kelly Services
Nashville, TN 37230
Every day, Kelly Services connects professionals with opportunities to advance their careers. We currently have an exciting DIRECT HIRE opportunity as a Quality Engineer for a top fortune 500 company in Nashville TN

**Title:** Quality Engineer

**Duration:** DIRECT HIRE position

**Location:** Nashville TN

**Essential Duties and Responsibilities:**

+ Responsible for ensuring compliance of all qualifications and re-qualification on Equipment and software systems within the Single Use Technologies business. These best-in-class systems are used to develop and commercially manufacture biopharmaceutical medicines that are used to treat diseases and improve the quality of life of patients.

+ Responsible for implementing and maintaining the clients processes and procedures used to validate customer systems in a scalable, efficient manner.

+ Additionally, this individual is responsible for leading the validation initiative of large and/or highly customized systems which includes deliverable definition, schedule creation/alignment, protocol development/execution, discrepancy management, and project close-out.

+ This role will also lead CAPA investigations for internal quality issues and customer complaints.

+ The role demands a solid technical background across a variety of scientific fields and fundamentals on Validation Lifecycle which includes Master Validation Planning (MVP), Change Control Management, Risk Assessments, User Requirement Specifications (URS), Factory Acceptance Test (FAT), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ).


+ Development and maintenance of Master Validation Master Plan for site

+ Participate in technical aspects of equipment and software validation at the site, including Equipment Qualifications and re-qualifications

+ Support the validation function by assisting with validation documentation, executing qualification protocols and compiling data

+ Lead CAPA investigations

+ Lead multi-functional team members supporting the Customer Complaint Process

+ Execute Risk and Impact Assessments

+ Interface directly with customers and internal groups

+ Drive product and process changes to improve product quality

+ Good understanding of GAMP, cGMP, GDP, and regulatory requirements for automated systems

+ Computer Systems Validation

+ Attention to detail and ability to identify and remediate issues found during testing

+ Highly effective verbal and written skills, including technical authorship

+ Self-motivated, proactive, and capable of adhering to strict deadlines

+ Ability to work well under pressure and multi-task

+ Innovative thinking and problem-solving skills (root cause analysis, CAPA)

+ Demonstrated knowledge of Quality Management System tools

+ Understanding of plastics- materials, properties, manufacturing processes, and product assembly.

+ Excellent interpersonal, organizational, and influencing skills

+ Proficient with Microsoft tools; Word, Excel, Power Point, Visio, Teams; MiniTab.

**Education / Experience:**

+ Bachelors degree in Engineering field or 5 years direct Quality Engineering/Validation experience

+ Minimum 5 years of validation experience

+ 5 years of hands-on experience leading validation projects which includes developing, executing, and closing out of FAT, SAT, and IQ/OQ/PQ protocols

+ Experience working in a regulated environment (e.g. ISO 13485:2016, 21 CFR 820, MDSAP)

+ ASQ certification is desired

**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 contact Michelle Niemira ( ) for immediate consideration.

**Why Kelly?**

+ 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

+ A competitive hourly pay rate with weekly checks

+ Access to newly expanded Medical Plan options

+ Online continuing education via the Kelly Learning Center

+ Several employee discounts

+ And more!

**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.
Posted: 2021-09-13 Expires: 2021-10-14

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Quality Engineer

Kelly Services
Nashville, TN 37230

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