West Caldwell, NJ
This position is responsible for all aspects of compliance. Prepares and implements SOP's relating to assigned portions of the quality system and performs training on quality procedures for staff.
- Train current and new employees in GMP and GDP.
- 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 such as investigation summary reports and change management records.
- Write and/or revise Standard Operating Procedures (SOPs) in a timely manner to meet the needs of the business.
- Oversee the Internal Audit Process, audit schedule, performing audits, audit reporting, and audit non-conformities corrective actions. Perform supplier audits as needed.
- Handle all non-conforming materials, either incoming components or in-process assemblies, complaints and eMDRs. Evaluate the need for a CAPA. Issue SCARs to suppliers.
- Track and trend all non-conformances.
- Review Change Authorizations
- Lead Corrective and Preventive action system (CAPA) and Supplier Corrective Action Requests/Reports (SCAR), assuring that it supports the needs of the business and complies with applicable regulations.
- Represent Quality for Design Controls and Verification/Validation activities.
- Perform DHR reviews and approvals.
- Support Quality during agency inspections and audits.
- Make logical and reasonable decisions based on procedures and regulations with minor supervision.
- Participate in Design review meeting
- Manage monthly metrics for Quality System
- Support QA Manager
- BS Degree, or higher, preferred
- Must have a minimum of four years Quality Assurance experience in Medical Device
- Manufacturing environment
- Previous experience in all aspects of Compliance in the Medical Device Industry
- Previous experience managing product complaints and Corrective and Preventive Action (CAPA) systems
- Working knowledge of 21CFR820, ISO 13485 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
- Excellent communication skills, both written and verbal
- Ability to work independently, participate on teams and lead teams
- Ability to read engineering drawings
- Must have an understanding of Document Control function.
- Understanding of QSR, ISO 9001, ISO 13485 and Risk Management 14971
- Ability to promote quality awareness and continuous improvement methodologies.
- Knowledge of applicable Quality Software requirements
- Excellent organizational and management skills
- Team oriented with the ability to successfully facilitate team meetings relating to the function
Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.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/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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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