Job Description

🌟 Now Hiring: Senior Manager – Quality Systems🌟

📍 Minnetonka, MN | On-Site | 55343

💼 Contract Duration : 1 Year

💵 Pay Rate : $75–$78/hr (W2)

📍 Location : Minnetonka, Minnesota 55343 (On-Site)

Join a mission-driven team making a real difference in healthcare!

We’re seeking a Senior Manager – Quality Systems to lead quality initiatives at the forefront of the life sciences industry. This is a high-impact role within a dynamic organization committed to product excellence, patient safety, and regulatory compliance.

🔍 Position Overview

As the Senior Manager – Quality Systems, you will oversee and enhance our Quality Management System (QMS), ensuring compliance with FDA and international standards. You’ll lead audits, drive system harmonization, manage product release processes, and oversee equipment administration across cross-functional teams.

You’ll thrive here if you're strategic, detail-oriented, and passionate about advancing healthcare through quality systems excellence.

✅ Key Responsibilities

• Administer and optimize quality systems in compliance with 21 CFR 210, 211, 820, ISO 13485, ICH Guidelines , and more.
• Lead internal/external audits, CAPA, Management Review, deviation management, and field action processes.
• Oversee product release and batch record compliance.
• Champion equipment qualification and calibration activities.
• Mentor and lead a high-performing quality systems team.
• Collaborate cross-functionally to drive continuous improvement and QMS harmonization across company sites.
• Support Software Quality Assurance and use of eQMS tools.
• Ensure timely responses to customer complaints and regulatory reporting (MDR).

🎓 Qualifications

• BS/BA in Engineering or related scientific field required.
• 8+ years in life sciences with 5+ years in quality leadership.
• Proven experience managing diverse teams and fostering collaboration.
• Deep understanding of GXP, ISO, QSR, ICH, EU GMP, and other global regulations.
• Strong manufacturing/operations background—especially with drug-device combination products , medical devices , or aseptic pharmaceuticals .
• Excellent problem-solving and communication skills.
• Experience working in both vertically integrated and virtually structured environments.

🌟 What Makes This Opportunity Unique?

• Make a real impact on healthcare product quality and patient outcomes.
• Work in a collaborative environment where your expertise is valued.
• Lead key quality initiatives with a high degree of autonomy.
• Competitive W2 hourly rate with long-term career potential.

EQUAL EMPLOYMENT OPPORTUNITY STATEMENT:

Suna Solutions provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Applicants, with criminal histories, are considered in a manner that is consistent with local, state, and federal laws.

REQUESTING AN ACCOMODATION

Suna Solutions is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Suna Solutions and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired.

If you would like to be considered for employment opportunities with Suna Solutions and have accommodation needs for a disability or religious observance, please call us at 1 (888) 223-4788, send us an email or speak with your recruiter.

PAY TRANSPARENCY POLICY STATEMENT

Compensation for roles at Suna Solutions varies depending on a wide array of factors including but not limited to the specific client, office or remote location, role, skill set and level of experience. As required by local law, Suna Solutions provides a reasonable pay scale to include the hourly or salary range that Suna Solutions reasonably expects to pay for roles that may be hired in California, Colorado, New York City or Washington.

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