The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate’s/applicant’s qualifications, skills, and level of experience as well as the geographical location of the position.

Applicants must be legally authorized to work in the United States. Sponsorship not available.

Our client is seeking a Senior Validation Quality Engineer in Raleigh, NC

Role Description

• This position will provide validation, engineering and technical support for all facilities supporting Manufacturing and Distribution. It will coordinate and execute product and process validations as appropriate to the Quality Department. It will evaluate the operation of Manufacturing and Quality activities in relation to compliance to Quality Standards and Regulations and recommend where corrections or improvements are indicated. The position will provide direct support to Quality Management/Quality personnel regarding operation of the department and Quality System. It will provide support to other departmental activities as directed.

• Oversee the operation of the Quality System process related to product, process, and/or test method Validation and Re-Validation. Oversee the Installation, Operational and Performance Qualification activities for equipment, product, or systems installed including those requiring computerized operation/interfacing. • Coordinate other activities associated with installation and proper configuration of new equipment as directed. Provide assistance to the Manufacturers and R&D departments in the development and validation of new products and Manufacturing/Quality Control processes. Review and approve internal operating procedures and specifications.
• Support NCR and CAPA: Capture data associated with product deviations, product non-conformances, CAPAs, scrap and rework, and analyzing the data for the purpose of Quality Improvement and reporting.
• Quality Improvement – Data Analysis: Provide leadership and direction and promote Quality Improvement Processes. Coordinate, and analyze databases associated with oversight of the Quality System and its reporting process.
• Quality initiatives: Provide quality engineering support for supplier changes and resolution of issues at suppliers. Identifies new quality improvement initiatives / projects in accordance with cGMP expectations to improve compliance, quality levels (reducing defects), and improve operational efficiencies. Works with manufacturing and other functional groups on manufacturing regulatory compliance issue. Support training program by delivering assigned training tasks.
• Inspections: Support with federal, state, and local regulatory officials during regulatory inspections. Support in internal and vendor quality system audits as applicable.
• Adherence to regulations:
Assist with adherence to all Federal, State and Local Regulations controlling the manufacture of medical devices.
• Other duties as assigned: Provides support to Quality Management personnel and perform other duties as assigned.

Skills & Requirements

• Bachelor's Degree Physical Science or Engineering, or equivalent experience.
• 3-5 years Minimum
in Medical Device or Pharmaceutical Industry or similar experience.
• 3-5 years Minimum
in a Quality Role.
• 3-5 years Minimum in a Validation Engineering Role.
• Minimum 2 years working with electromechanical devices.
• ASQ Certification as a Quality Engineer or equivalent.
• Minimum 3 years working with electromechanical devices.
• ASQ Certification as a Quality Engineer.
• Knowledge of quality requirements for medical device / pharmaceutical organization.
Strong technical writing skills.
• Strong technical and general problem-solving skills required; experience with NCR/CAPA processes.
• Computer skills in Microsoft Word, Excel, PowerPoint, Visio; Adobe; and Quality System Management Software.
• Experience with Statistical Analysis of Data.
• Experience with statistical sampling requirements for Process Validation.
• Familiar with ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations.
• Highly effective communication skills. Ability to work with company staff and communicate effectively throughout the organization.
• Manage multiple priorities and work with interruptions.
• Ability to work with minimal supervision and to make effective decisions for issues of a diverse and complex scope when required.

Benefits/Other Compensation

This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays’ guiding principles is ‘do the right thing’.
We also believe that actions speak louder than words.
In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.

In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.

Drug testing may be required; please contact a recruiter for more information.

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