Quality Systems Specialist

Overview

Position summary

The Quality Systems Specialist will be responsible for developing, implementing, and maintaining the quality management system.   

Responsibilities

Essential Job Functions                                                      

• 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. The audit program is responsible for maintaining and improving a quality system which meets the requirements ISO 13485, and FDA QSR
• 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
• Read, understand, and follow work instructions and standard work
• 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
• Ability to work in a manufacturing environment

Qualifications

Minimum Requirements, Education & Experience (incl. KSA’s and certifications)

• 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

Desirable Criteria & Qualifications

• Quality systems experience in a manufacturing setting
• Continuing education; including participation in local chapters, associations, and/or organizations

Pay Range

Pay Range Details

This pay range reflects the base hourly rate or annual salary for positions within this job grade, based on our market-based pay structures. Actual compensation will depend on factors such as skills, relevant experience, education, internal equity, business needs, and local market conditions. While the full hiring range is shared for transparency, offers are rarely made at the minimum or maximum of the range.

Company Benefits

All Employees:

Our 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, an employee death benefit, and employee sick and safe leave are available to all Cretex employees. 

20+hours:

Cretex’s medical benefit package includes: 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; a pre-tax health savings account, healthcare and dependent care pre-tax reimbursement accounts; paid holidays, paid time off; and our discretionary profit sharing program are available to employees working 20+ hours/week. 

30+ hours:

Parental Leave, accident and critical illness benefits, optional employee, spouse, and child life; short and long term disability; company provided life insurance; and tuition assistance programs are available to employees working 30+ hours per week. 

(Some benefits are subject to eligibility criteria.)

Applicants will receive consideration for employment regardless of their race, color, creed, religion, national origin, sex, sexual orientation, gender identity, disability, age, veteran status, marital status, family status, status with regard to public assistance, or any other protected status as required by law.  

Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.