Kelly Science is seeking a **Quality Assurance Associate** for a growing company located near **Caldwell, NJ** .


**Shift:** 8:00am-4:30pm


**Employment Type** : Full Time; Direct Hire


**Summary:**


This position is responsible for all aspects of compliance. Prepares and implements SOPs relating to assigned portions of the quality system and performs training on quality procedures for staff.


**Job Duties include:**


+ Train current and new employees in GMP and GDP and support Quality during agency inspections and audits.

+ Work with Purchasing to define and lead supplier quality initiatives and requirements, including supplier qualification criteria, supplier monitoring and corrective action. Define and implement key performance metrics trending for suppliers.

+ Leading cross-functional teams to implement continuous improvements.


+ Write technical reports including investigation summary reports and change management records and revise Standard Operating Procedures (SOPs)Oversee the Internal Audit Process, audit schedule, performing audits, audit reporting, and audit non-conformities corrective actions.

+ Perform supplier audits as needed.


+ Handle, track and trend all non-conforming materials, either incoming components or in-process assemblies, complaints and eMDRs.

+ Evaluate the need for a CAPA, issue SCARs to suppliers and review Change Authorizations

+ Lead CAPA and SCAR, assuring that it supports the needs of the business and complies with applicable regulations.

+ Represent Quality for Design Controls and Verification/Validation activities and perform DHR reviews and approvals.

+ Participate in Design review meeting and manage monthly metrics for Quality System


**Requirements:**


+ BS Degree, or higher, preferred

+ Minimum of 2-4 years Quality Assurance experience in Medical Device Manufacturing

+ Compliance in the Medical Device Industry

+ Previous experience managing product complaints and CAPA systems

+ Working knowledge of 21CFR820, ISO 13485, ISO 9001 and 14971

+ Experience working in an ISO certified and /or QSR regulated quality system, interpreting and implementing regulations and requirements (QSR and ISO) and auditing their performance

+ Ability to read engineering drawings


**Interested? Apply today and send updated resumes to Chelsea.Crosier@kellyscientific.com for immediate consideration!**


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.


**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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.