Regulatory Affairs / Quality Assurance Specialist

**Regulatory Affairs Quality Assurance Specialist**

What's next for you? This great job. Kelly is looking for a dynamic **Regulatory Affairs / Quality Assurance Specialist** for our top biomedical client in Redmond, WA. The ideal candidate will have 2+ years' experience in a Quality Assurance role in a manufacturing environment with strong experience with NC's and CAPA's. This is a one-year contract role with possibility of extension. Hybrid, on-site, role. All candidates must be local to Redmond, WA.

*** MUST BE ABLE TO WORK AS AN EMPLOYEE (ON W-2 BASIS) *** NO C2C, 1099, etc. ***

+ Shift: 8:00am to 5:00pm

+ Location: *HYBRID, remote/on-site. All candidate must be local to Redmond, WA.

+ Pay: $57.00 - 71.00/hour DOE & EDU

**In this role you will:**

+ Conduct, write, and own CAPA investigations to determine the probable and verified root causes for nonconformities/out-of-specification events.

+ Ensure compliance to CAPA processes and procedures.

+ Support and implementation of changes related to projects in the product lifecycle system and quality management system.

+ Co-ordinates, prepares, and routes document packages for submissions. Liaise with relevant functional groups to gather all necessary changes and information.

+ Reviews and verifies document records to ensure the documentation complies with regulations and internal quality control practices.

+ May interact with regulatory agencies.

+ Works on problems of complex scope where data analysis requires evaluation of specific factors.

+ Utilizes independent judgment within broad parameters to determine an appropriate solution. May determine methods and procedures on new projects and may provide guidance to other lower-level staff.

+ This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision.

**Required:**

+ Requires a bachelor's degree.

+ Must be an expert with Microsoft Office Tools including Outlook, Word, Excel, SharePoint, and Teams

+ Must have previous experience in a regulated environment and working in a quality system and ISO compliance

+ Must have previous experience with document/procedure writing, updating, and management in a regulated environment.

+ Must have previous experience with NC's and CAPA's.

+ Support of RAQA projects including NC's, CAPA's, and process/document updates.

**Why Kelly?**

As a Kelly employee, you'll have access to world-class perks, including:

+ Kelly-sponsored Affordable Care Act health care coverage available to eligible employees

+ *Group insurance options

+ Service bonus plan

+ Holiday pay plan

+ Weekly electronic pay options

+ Online training campus that provides more than 3,000 free courses to help improve and develop skills

+ Exclusive online employee community

+ Employee assistance program available at no cost

+ Corporate discounts

+ Transportation Spending Accounts

*Offered and administered by Leslie & Associates. These plans are not sponsored by Kelly Services.

**Apply Today!**

*Important information: This position is recruited by a remote, national, Kelly office, NOT your local Kelly branch. Applicant must have a legal right to work in the US without sponsorship or VISA transfer for this position. There is no relocation budgeted for this position. If this position requires you to relocate you will be responsible for those costs

**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, 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/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.