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Quality and Regulatory Specialist

Rose Medical -
Grand Rapids, MI

Quick Apply

Job Details

Full-time
$75,000 - $95,000 a year
2 days ago

Benefits

Paid holidays
Disability insurance
Tuition reimbursement
Paid time off
401(k) 4% Match
401(k) matching
Employee discount
Life insurance
Childcare

Qualifications

Corrective and preventive actions (CAPA)

Full Job Description

Join Rose Medical – Ensure Quality, Drive Compliance, and Make a Difference

Position Title: Quality and Regulatory Specialist
Location: Grand Rapids, MI
Department: Operations
Reports To: General Manager

Rose Medical is a fast-growing medical device manufacturer dedicated to producing high-quality, innovative products that make a difference in people’s lives. We are seeking a Quality and Regulatory Specialist to manage and continually improve our Quality Management System while ensuring compliance with ISO 13485 and FDA regulations.

This is a hands-on, detail-driven position that plays a vital role in maintaining Rose Medical’s reputation for quality and integrity. You’ll work across teams to ensure processes meet regulatory standards, audits run smoothly, and new requirements are implemented effectively.

What You’ll Do

Manage third-party audits (ISO 13485, customer, and FDA inspections).
Lead and execute the CAPA process, ensuring timely and effective resolution of issues.
Maintain and manage the Approved Supplier List and supplier controls.
Coordinate and execute internal audits and QSP training programs.
Keep presentations and documentation current while conducting training sessions.
Coordinate and manage equipment calibrations and environmental condition reviews.
Stay current with ISO and FDA GMP standards, implementing new requirements as needed.
Provide measurement and analysis data for management review and quality objectives.
Assist with contractual documentation (quality agreements, NDAs, etc.) and document control.
Support the engineering team with process validation and risk management activities.
Investigate nonconformances, coordinate corrective actions, and follow through to prevent recurrence.
Complete customer surveys and other compliance documentation as required.

What We’re Looking For

Bachelor of Science degree or equivalent combination of education and experience.
5+ years of experience in a Quality Systems role, preferably in medical device manufacturing.
Strong working knowledge of ISO 13485 and FDA QSRs.
Experience with CAPA, supplier controls, audits, validation, and risk management.
Solid understanding of basic statistical and engineering principles.
Ability to thrive in a fast-paced environment and manage multiple priorities effectively.
Excellent communication and collaboration skills; positive, team-oriented mindset.
Familiarity with Product Data Management systems preferred.

What We Offer

At Rose Medical, we believe our people are our strength — and we back that up with a competitive, supportive benefits package:

Competitive compensation – Salary based on experience and qualifications
Quarterly bonus program – Everyone shares in Rose’s success!
Paid time off and holidays – A generous package to support work-life balance, with paid holidays available immediately
Comprehensive benefits after 30 days including:
- Medical (with diabetic supplies covered at 100%)
- Dental (includes orthodontics for kids and adults)
- Vision
- 401(k) with 4% company match
- Disability and life insurance options
Tuition reimbursement program – Supporting continued professional growth and development
Childcare discount program – Helping support working parents with access to reduced childcare costs

Why Rose Medical?

Be part of a growing company with a mission to improve lives through innovation and quality.
Collaborate across departments to drive meaningful, lasting improvements.
Work in a culture rooted in Diversity, Growth, Stewardship, Integrity, Innovation, Productivity, and One Rose.
Competitive pay, comprehensive benefits, and long-term growth opportunities.

Apply Today
If you’re passionate about quality, thrive in a collaborative environment, and want your work to make a real impact, we’d love to hear from you.

Quick Apply

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Join Rose Medical – Ensure Quality, Drive Compliance, and Make a Difference

What You’ll Do

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Why Rose Medical?

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