New · posted Nov 6
The Cretex Companies · Medical Devices
Quality Systems Specialist
- Brooklyn Park, MN
- On-site
- Full-time
- Associate & Specialist
The role
The Quality Systems Specialist will be responsible for developing, implementing, and maintaining the quality management system.
Desired Criteria
- Quality systems experience in a manufacturing setting
- Continuing education; including participation in local chapters, associations, and/or organizations
What is it like to work at Cretex Medical?
We recognize the contribution of every individual and promote growth, safety and security for all our employees. Cretex Medical values performance and pays competitive wages along with a rich benefit package. We offer a positive work environment with a focus on continuous improvement.
Here are some of things that employees have said about working for Cretex Medical:
- “The culture at Cretex is collaborative. Everyone here is willing to help you whether it is a director, a machinist, or your boss. Everyone is always willing to help you figure out a project and get it done right.”
- “I would tell potential interns that Cretex is a great company to work for. It has set a high bar for corporate culture as well as the quality of work you can do. I would definitely recommend it.”
- “I learned that I really like the medical device industry. The importance and the gravity of what we do here is felt by the employees. You can have that passion in your work because you know what you are striving for is to save lives.”
We encourage you to explore the many opportunities Cretex Medical can offer you as a valued team member.
What you need
- Bachelor’s degree in a related field or equivalent relevant experience
- 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
- Ability to work in a manufacturing environment
- Ability to travel up to 15%
What you'll do
- May assist or lead second and third-party audits, including audit preparation, execution, reporting and follow-up activities
- May manage or lead the internal audit including implementation of effective corrective actions.
- Perform process and product audits to identify gaps and deficiencies and implement process improvement initiatives utilizing lean techniques
- Assist in maintaining a Global Quality System model that scales with organizational growth
- Implement, monitor, lead and assist Corrective and Preventive Actions (CAPAs) that result from second, third-party, and internal audits.
- Assist in maintaining 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
- 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
Pay
$62,000 – $93,000 a year
Employer providedUSD $62,000.00 - USD $93,000.00 /Yr.
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.
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.
Where you'll work
Brooklyn Park, MNOn-siteOpen in Maps (opens in a new tab)
More jobs in Brooklyn Park, MNWorking conditions
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.
From the posting
About Cretex
About Cretex Medical
Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our customers view us as a trusted partner in the areas of injection molding, laser processing, metal stamping and device assembly. Learn more at www.cretexmedical.com.
Equal opportunity, accessibility and legal noticesThe Cretex Companies's statements, word for word
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.
Job intelligence
The context around this role
Live data · November 6, 2026
Salary intelligence
How the pay compares
This role's midpoint is 10% below the US median for Quality Systems & Document Control roles at this level.
This roleEmployer provided
Associate & Specialist roles in the US18 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $62,000 | — | $93,000 |
| All US (middle half) | $70,000 | $86,500 | $102,500 |
This role: The Cretex Companies's own published range. Comparisons: the base pay employers published on open Quality Systems & Document Control roles at the same level on Regulatory Jobs, November 6, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Systems & Document Control
The general path across 84 open Quality Systems & Document Control roles on Regulatory Jobs, with the titles they carry most. Not Cretex's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 43 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership11
- Quality systems and risk10
- GMP and compliance6
- Documentation and SOPs1
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Systems & Document Control work in medical devices, led by the one this posting names, each linked to the agency or standards body that publishes it.
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devicesNamed in the posting
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDAFDA Computer Software Assurance(official source, opens in a new tab)Risk-based assurance for production and quality system software
- FDAMDSAP(official source, opens in a new tab)The Medical Device Single Audit Program shared by five regulators
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- FDA21 CFR Part 803(official source, opens in a new tab)Medical device reporting of deaths, serious injuries and malfunctions
- FDA21 CFR Part 806(official source, opens in a new tab)Reports of medical device corrections and removals
- FDA21 CFR Part 830 (UDI)(official source, opens in a new tab)Unique device identification and the GUDID database
- ISOISO 9001(official source, opens in a new tab)Quality management systems requirements
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- FDA21 CFR Part 807(official source, opens in a new tab)Establishment registration, device listing and premarket notification
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
- Health CanadaCanada Medical Devices Regulations(official source, opens in a new tab)Health Canada's licensing and quality requirements for medical devices (SOR/98-282)
Company hiring pulse
Cretex on Regulatory Jobs
- 28
- Open roles
- 28
- Distinct roles
- 4
- Locations
By discipline
- Quality29 100%
By level
- Associate & Specialist20 69%
- Senior & Principal6 21%
- Manager3 10%
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Quality Systems Specialist at Cretex
Applications close October 28. $62K–$93K a year, employer provided.