IntePros · 1 week ago
Quality Manager
Minneapolis, MN
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expIntePros is seeking a Quality Manager to lead their quality assurance department. This role will involve developing and implementing quality management systems in alignment with FDA and ISO requirements while managing a team to ensure product quality and compliance.
ConsultingInformation TechnologyStaffing Agency
Responsibilities
Develop, deploy, and execute quality policies, quality objectives, and quality plans that support the corporate strategic business goals and conform to customer, internal, ISO 9001:2015 and EN ISO 13485:2016, regulatory and legal requirements
Support, develop, implement, and maintain all QMS processes and procedures, including but not limited to, Complaint Handling, Design and Development, Change Control, Risk Management, Corrective and Preventive Action, Internal Audits, Supplier Quality, Process Control, Document Control and Identification and Traceability
Establish and lead a high-performing team of Quality Engineers, Quality Supervisor and Document Control, providing mentorship and coaching to staff as needed
Ensure effective coordination of investigations, root cause analysis, risk assessments, field actions and implementation of change control and corrective and preventive actions to the adhered timelines
Responsible for implementation, support, validation of computer system QMS modules
Monitor and assess the QMS processes for compliance, effectiveness, continued alignment with applicable regulatory and statutory requirements, and opportunities for improvement, ensuring continued certification to applicable standards
Maintain Quality System Dashboards, Scorecards / Key Performance Indicators for the quality system processes. Review and monitor trends, communicating issues to department management. Contribute to and assist in providing quality system training as appropriate
Collect, analyze, and present data on the QMS during Management Review Meetings. Drive process implementation including quality control plans, validation, qualifications (IQ, OQ, PQ) and root cause – corrective action
Creating management level presentations and reports
Ensure qualification, selection and monitoring of suppliers and any related quality issues
Support a culture of Operational Excellence, inclusive of lean and six sigma principles
Act as the Deputy Management Representative should need arise
Act as a representative for external audits; customers, regulatory authorities, and registration agencies
Qualification
Required
Bachelor's degree in Engineering, Sciences, Quality, or relevant experience
8 years of experience in Quality Assurance or related management experience in manufacturing engineering or operations discipline, in a regulated field
5 years of leadership experience
Experience with ISO 13485, ISO 14971 and GMP
Auditing, writing procedures, supplier quality assurance, verification & validation
In depth knowledge of FDA Quality System Regulation, Good Manufacturing Practices, 21 CFR Part 820 and cleanroom standards, or other relevant regulated requirements
Excellent working knowledge of quality tools, variable and attribute sampling plans, root cause analysis, DOE, Statistics, Lean Manufacturing, and Six Sigma – an asset
Demonstrated leadership skills with the ability to build and maintain an efficient, effective organization with a team focused on continual improvement
Ability to prioritize, plan, and evaluate deliverables to established strategic goals and timelines
Ability to consistently achieve short and long-term business results
Ability to follow through on commitments and holds team members accountable
Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher)
Clear and effective verbal and written communication skills
Attention to detail and organizational skills
Ability to work in a fast-paced team environment
Ability to prioritize and multitask
Preferred
Continuing education, including participation in local chapters, associations, and/or organizations
Company
IntePros
IntePros is an established, woman-owned, privately-held technology and business services consulting agency committed to building long-term relationships and helping more companies leverage the power of a more diverse workforce.
201-500 employees
H1B Sponsorship
IntePros 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 (3)
2024 (3)
2023 (6)
2022 (7)
2021 (6)
2020 (13)
Funding
Current Stage
Growth StageLeadership Team
Loren Kovalcik
CEO
Company data provided by crunchbase