Job Description

Job Description

Functional Description:

The Quality Systems Specialist is instrumental in ensuring the successful implementation of our ISO 13485 certified quality management system policies and procedures. They play a crucial role in ensuring that our processes are upheld and that products shipped to our customers meet our standards of quality and our customer’s requirements.

Scope of Outcomes:

The Quality Systems Specialist functions under the direction of the Regulatory Manager. Core responsibilities for this role include:

• Ensure quality procedures are being followed to ensure quality built into our products, start to finish.
• Revise procedures and documentation as necessary, in accordance with the document change procedure.
• Assure calibration program is current and maintained.
• Schedule maintenance, cleaning and calibration for the equipment in the shop to ensure proper operation.
• Review, coordination, and closure of customer feedback (complaints, warranty, DOA’s).
• Take appropriate corrective action in accordance with the CAPA process (internal findings, external findings, customer complaints, etc.).
• Assure document control and change management processes are maintained.
• Ensure all WA DOH requirements are satisfied for the use of x-ray equipment in production.
• Management of radiation area monitors.
• Collaborate with procurement to review and approve new vendors.
• Collaborate with procurement to evaluate the performance of current vendors and maintain vendor certifications, according to our quality procedure.
• Participate in internal and external audits.
• Perform final QC inspections of all product going out the door.
• Perform quarterly ESD audits.
• Perform quarterly Chemical Audits.
• Monitor production methods, product safety, product quality, and risk management.
• Coordinate quality awareness training for personnel.
• Monitor and maintain site employee training matrix.
• Monitor customer feedback for trends and opportunities for improvement.
• Monitor non-conforming product for trends and take corrective action as appropriate.
• Participate in regular touch base calls with the Regulatory Manager to communicate updates, concerns, risks, resource needs, and opportunities for improvement.
• All other duties as assigned.

Job Requirements:

Preferred candidates will possess:

• Bachelor’s degree in relevant field or an equivalent combination of skills, training, and experience
• 2+ years of experience with a quality management system
• Knowledge and familiarity with ISO 13485 and/or ISO 9001
• Good communication and project management skills
• Independent thinker and ability to prioritize
• Excellent written and verbal communication skills
• Ability to work in a team environment as well as independently
• Ability to work well in a fast-paced environment while managing multiple projects
• Attention to detail and great organizational skills.

Benefits:

• RSA offers the following benefits as part of its Total Rewards program:
• Medical (100% paid by employer), dental (100% paid by employer), vision, Short Term and Long Term disability (100% paid by employer), Life and AD&D insurance (100% paid by employer), cancer, accident, FSA, HSA, 401(k) 6% dollar for dollar matching. You will be eligible for health and welfare benefits the first of the month following your date of hire.
• Longevity bonus
• PTO: Three (3) weeks (120 hours) of PTO accrual-based.
• Ten (10) paid holidays.
• Excellent opportunity for development and advancement as part of our employee engagement model
• Standard hours of Monday – Friday, 8 AM to 5 PM