Quality Systems Specialist
About The Position
The Quality Systems Specialist will be responsible for developing, implementing, and maintaining the quality management system. This role involves leading audits, managing the internal audit program, performing process and product audits, and providing leadership in regulatory matters. The specialist will also develop and maintain a Global Quality System model, represent Quality on the Supplier Qualification Team, and coordinate supplier audits. Additionally, they will identify and develop QMS training programs, partner with quality and operations for improvements, and implement/maintain Global Quality System software. The role requires supporting and complying with the company Quality System, ISO, and medical device requirements, as well as partnering with other business segments to understand customer needs and ensure business systems function properly. Maintaining an organized work area and participating in the Operational Excellence Program are also key aspects of the position.
Requirements
- 3 years of experience working with quality management systems
- Experience with ISO 13485:2016 and FDA
- Lead Auditor Certification
- Ability to consistently achieve short and long term business results
- Ability to prioritize work and manage multiple tasks when needed
- Ability to follow through on commitments and hold team members accountable
- Consistently produces work that meets the customer’s requirements
- Focus on Operational Excellence
- Project management skills
- Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher)
- Clear and effective verbal and written communication skills
- Attention to detail
- Organizational skills
- Ability to work in a fast-paced team environment
- Ability to prioritize and multitask
Nice To Haves
- Quality systems experience in a manufacturing setting
- Continuing education; including participation in local chapters, associations, and/or organizations
Responsibilities
- Lead second and third-party audits, including audit preparation, execution, reporting and follow-up activities
- Manage the internal audit program from the selection and training of the internal audit group through the implementation of effective corrective actions.
- Perform process and product audits to identify gaps and deficiencies and implement process improvement initiatives utilizing lean techniques
- Provide leadership in Company regulatory matters and support customers regarding their regulatory needs
- Develop and maintain a Global Quality System model that scales with organizational growth
- Represent Quality on the Supplier Qualification Team. Co-chair the supplier performance meetings and ensure program requirements are up-to-date, including the Approved Supplier List.
- Lead/coordinate Supplier audits
- Identify, develop, and maintain relevant QMS training programs to promote quality awareness and ensure compliance to company policies and procedures
- Partner with quality and operations to implement quality system improvements
- Implement, maintain, and provide issue resolution in regard to the Global Quality System software
- Read, understand, and follow work instructions and standard work
- Support and comply with the company Quality System, ISO, and medical device requirements
- Partner with other business segments: sales/marketing, customer service, engineering, quality, and finance
- Understand customer needs and the core business markets we serve
- Ensure business systems are implemented, maintained, and functioning properly
- Participate in required company meetings
- Maintain an organized work area (5S)
- Participate in the Operational Excellence Program
- Complete all other work duties as assigned
Benefits
- 401k retirement savings plan with a company match contribution
- Onsite health clinics
- Discretionary holiday bonus program (based on years of service)
- Cretex University
- 24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost
- Wellness program with incentives
- Employee death benefit
- Employee sick and safe leave
- Comprehensive medical insurance with access to virtual providers
- Dental insurance (Little Partners Dental benefit covers services 100 percent for children 12 and younger when seen by a Health Partners in network provider)
- Vision insurance
- Pre-tax health savings account
- Healthcare and dependent care pre-tax reimbursement accounts
- Paid holidays
- Paid time off
- Discretionary profit sharing program
- Parental Leave
- Accident and critical illness benefits
- Optional employee, spouse, and child life
- Short and long term disability
- Company provided life insurance
- Tuition assistance programs
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
