ISurTec · 2 days ago
Sr. Manager, Quality & Regulatory Compliance
Twin Cities Area
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expISurTec is a company focused on quality assurance and regulatory compliance in manufacturing and product development. The Sr. Manager of Quality will lead the strategic vision for Quality Assurance, Quality Control, and regulatory compliance, ensuring a culture of operational excellence and continuous improvement.
ChemicalMedicalMedical Device
Responsibilities
Provide strategic direction and leadership for ISURTEC’s Quality organization, including Quality Assurance, Quality Control, Document Control, and Compliance functions
Develop and drive a multi-year quality strategy aligned with ISURTEC’s business goals, operational scaling, and technological evolution
Foster a strong culture of quality, accountability, risk management, and continuous improvement across the company
Serve as Quality Management Representative, ensuring effectiveness of the Quality Management System (QMS) and reporting on performance to the Management Team
Oversee the development, implementation, maintenance, and continuous enhancement of the QMS in compliance with ISO 9001, ISO 13485, FDA QSR (21 CFR Part 820), and other applicable standards and regulations
Ensure organizational readiness for surveillance, re-certification, customer, and regulatory audits; lead audit strategy, execution, and timely closure of findings
Maintain certifications and compliance documentation, ensuring alignment with evolving regulatory requirements
Provide high-level oversight of quality assurance throughout the full product lifecycle—from development through manufacturing, release, and post-market quality management
Ensure robust validation/qualification strategies for manufacturing equipment, processes, and products; approve validation plans and reports
Oversee nonconformance management, complaint handling, supplier quality, and change control processes
Monitor key quality metrics, analyze trends, and provide executive-level reporting with strategic recommendations
Lead supplier quality strategy, including evaluation, monitoring, performance management, and improvement initiatives for external providers
Oversee quality-related components of onboarding new customers, including review of quality agreements, customer audits, documentation, and compliance requirements
Strengthen customer confidence by maintaining consistent, transparent communication on quality performance and continuous improvement initiatives
Partner with R&D, Operations, and Engineering on new product introduction (NPI), process improvements, and technology transfer activities
Work closely with Operations leadership to optimize manufacturing processes, reduce quality risks, and ensure consistent product performance
Ensure company-wide training compliance and organizational readiness regarding QMS policies, procedures, and regulatory requirements
Oversee retention of samples, recordkeeping compliance, and traceability standards
Ensure quality-related compliance for shipping logistics, labeling, and documentation
Oversee data retention and protection strategy, including training
Drive adoption of digital tools, automation, and data systems to improve quality insights and operational efficiency
Qualification
Required
10+ years of progressive quality leadership experience in a regulated manufacturing environment, preferably in medical devices or advanced coatings technologies
Demonstrated success building and leading high-performing quality teams
Hands-on experience with ISO 13485, ISO 9001, and risk management under ISO
Extensive experience leading internal, customer, and regulatory audits
Proven strategic leadership and ability to influence at all organizational levels
Strong knowledge of QMS design, implementation, and continuous improvement
Familiarity with supply chain quality, inventory controls, and lab/cleanroom safety
Exceptional analytical, problem-solving, and decision-making abilities
Proficiency with quality systems, data analysis tools, and digital QMS platforms
Excellent communication, presentation, and interpersonal skills
Preferred
Master's degree in Quality, Regulatory Affairs, Engineering, or related technical/scientific field; Bachelor's degree with extensive experience considered
Experience with coating technologies and processes is highly desirable
Benefits
Medical benefits, 100% premium paid for employee
Dental benefits, 100% premium paid for employee
Vision benefits
Voluntary Life
ID Protection Plan
FSA Plan options
HSA Plan option
Life Insurance, Short-term, & Long-term disability
401k plan with company match
Tuition Reimbursement
PTO (Paid Time Off)
10 Paid Holidays
Company
ISurTec
ISurTec provides primer and lubricious coating formulations for medical devices.
11-50 employees
H1B Sponsorship
ISurTec has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2022 (1)
2021 (1)
2020 (1)
Funding
Current Stage
Early StageTotal Funding
$0.15MKey Investors
National Science Foundation
2012-12-19Grant· $0.15M
Leadership Team
Julie Helgason
Chief Financial Officer
Eric Guire
Chief Innovation Officer
Company data provided by crunchbase