Quality Specialist

Direct Hire Role!

55K-65K plus bonus

The Quality Specialist will provide support to the manufacturing process within a team orientated, customer-driven organization. This position will provide quality system and GMP support to the facility related to corrective actions/CAPA, change management, management reviews, customer complaints, training, document, and records management, nonconformance's, and audits.

Responsibilities

• Manages the site document management and change control processes, coordinates reviews both on site, with customers, and suppliers.
• Updates documents as required and performs bi-annual document reviews.
• Coordinates the site Nonconformance and MRB processes.
• Assist with the planning, implementation, and effectiveness verification of corrective and preventive actions.
• Assists production with the investigation of component and finished good non-conformances.
• Coordinates the receipt, investigation and response to customer complaints.
• With Manager, coordinates the site Quality System management reviews and associated activities.
• Coordinates and reports on key quality metrics and reports.
• Analytically assess data to determine trends and root causes.
• Reviews systems procedures and executed records to determine gaps and to identify areas for improvement.
• Administer the sites training program and training records.
• Prepares training materials and performs on-site training on relevant GMP topics for staff and new hires.
• Generates and maintains Device Master Records, Quality System Records and Device History Files.
• With Manager coordinates on-site customer, internal and ISO 13485 audits.
• Organizes any corrective and preventive actions that are an outcome of audits.
• Maintains all relevant GMP files in compliance with applicable regulatory and record retention requirements.
• Oversees the quality system requirements, testing and release of externally produced nasal swabs.
• Participates in site continuous improvement efforts and initiatives.
  

Qualifications

• Bachelor of science degree or 4 years or more of GMP experience in a FDA-regulated industry
• Knowledge of medical device quality systems (21 CFR 820, ISO 13485)
• 5 years or more experience in an FDA regulated environment preferably in a manufacturing facility
• Excellent verbal and written communications
• Ability to organize, prioritizes, and perform multiple tasks with minimal supervision
• Ability to work collaboratively with others to solve problems
• Works with a sense of urgency, good attention to detail, and follow-thru
• Extensive experience using Microsoft Word, Excel, Power Point and Adobe Acrobat

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, we're here every step of the way to find your dream engineering job.

About Kelly ??

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're 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 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.