Open Position

Quality Assurance Manager

Burnsville, MN

Basic Function

The Quality Assurance Manager is responsible for the quality assurance functions, ensuring compliance with Good Manufacturing Practices, Good Documentation Practices, Standard Operating Procedures, and other relevant policies, procedures, and regulations. This role involves managing the quality assurance team, conducting internal and external audits, leading cross-functional process improvement initiatives, and working closely with clients and stakeholders to maintain high-quality standards.

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Responsibilities

Hires, trains, and manages skilled staff to ensure high performance and accountability, collaboration, respect for diversity, and employee job satisfaction
Interprets government regulations, agency guidelines, industry standards, and internal policies to ensure compliance
Partners with management across departments to lead quality initiatives to develop and maintain a high performing, scalable, and compliant quality system
Leads audit and inspection preparation, resolution of audit and inspection findings, and liaises with auditing groups and inspectors through all stages of the audits
Manages electronic quality management system including document control and training activities
Provides Quality Engineering leadership to directly support medical device manufacturing
Leads manufacturing process development, process validation, monitoring, and improvement activities
Maintains equipment program including qualification, calibration, and maintenance
Manages nonconformance and CAPA systems
Produces and analyzes trend metrics and establishes necessary actions
Develops, recommends, and implements major changes in quality policies and procedures
Manages supplier evaluation, selection, and control, including supplier audits
Performs other related duties and responsibilities, as assigned

Qualifications

Bachelor’s degree in engineering or technical field
8+ years of related work experience in roles of increasing responsibility, impact, and scope in a manufacturing environment or an equivalent combination of education and work experience
3+ years experience managing people
Class III or Class II medical device experience strongly preferred
Must have experience across a broad range of quality assurance activities including a working knowledge of functions such as quality systems, document control, nonconformance and CAPA management, quality engineering, supplier management, microbiology, product and process design, and regulatory compliance
Comprehensive knowledge of GMP, ISO 13485, 21 CFR 820
Strong communication, analytical, and problem-solving skills
Demonstrated ability to effectively manage multiple projects and priorities
Skills in multiple computer-based tools and software such as Word, PowerPoint, Excel, and Adobe Acrobat