Job Title: Quality Assurance Manager
Department: Engineering/Quality Assurance
Location: Minneapolis, MN
Job Type: Full-Time, Salaried
Company Overview:
ViruTech a medical division of TMPI, is a leading technology firm specializing in innovative solutions for viral detection and prevention. With a mission to safeguard communities and organizations from viral threats, we are dedicated to developing cutting-edge technologies that enhance public health and safety.
The Role:
Our company is currently experiencing rapid growth and is in search of a highly skilled and experienced Senior Quality Assurance Engineer with a management track to join our growing team. The Senior Quality Assurance Engineer will play a pivotal role in ensuring the quality and reliability of our products and services while leading a team of quality assurance professionals. The ideal candidate will have a strong background in QA methodologies, team leadership, and project management, with experience in the medical device industry.
Role Duties and Responsibilities:
Quality Management:
- Develop and implement quality management strategies, policies, and procedures to ensure compliance with regulatory standards and industry best practices.
- Establish quality assurance metrics, KPIs, and objectives to measure and improve product quality and customer satisfaction.
- Conduct regular audits and assessments of internal processes, systems, and documentation to identify areas for improvement and ensure adherence to quality standards.
Team Leadership:
- Build, lead, and mentor a team of quality assurance professionals, providing guidance, support, and professional development opportunities.
- Delegate tasks effectively, ensuring alignment with project goals and timelines
- Foster a collaborative and inclusive team environment that encourages innovation, creativity, and continuous improvement.
Quality Assurance Processes:
- Develop and execute comprehensive test plans, test cases, and test scripts to validate software functionality, performance, and reliability.
- Implement automated testing tools and frameworks to streamline the testing process and improve efficiency.
- Perform regression testing, usability testing, and integration testing to identify defects and ensure product integrity.
Risk Management:
- Identify potential risks and vulnerabilities in product design, development, and implementation, and develop risk mitigation strategies.
- Monitor and analyze quality assurance data and metrics to proactively identify trends and areas of concern.
- Collaborate with cross-functional teams to prioritize and address high-risk areas and ensure timely resolution of quality issues.
Regulatory Compliance:
- Ensure compliance with regulatory requirements, industry standards, and customer specifications, including ISO, FDA, and other relevant regulations.
- Prepare and maintain documentation for regulatory submissions, audits, and inspections, ensuring accuracy, completeness, and timeliness.
Additional Responsibilities:
- Learn and adapt to the Quality Management System (QMS) established by QRX and accessible platforms.
- Lead the implementation of FDA regulations for documentation and ensure compliance with quality standards.
- Coordinate with colleges and universities for collaborative projects and partnerships.
- Participate in company meetings, contribute to various tasks, and program management documentation.
- The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this classification. They are not intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this position.
Minimum Role Qualifications:
- Bachelor's degree in computer science, engineering, biology, chemistry, or related field; advanced degree preferred.
- Minimum 3 years’ project management experience.
- Minimum 5 years’ experience in the medical device industry.
- At least 3 years of experience in capturing and integrating processes into QMS.
- Profound understanding of Quality Assurance (QA) methodologies, tools, and processes.
- Proven expertise of FDA regulations related to documentation.
- Quality certifications such as ISTQB are a plus.
- Strong leadership and team management skills.
- Excellent communication and collaboration abilities.
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Travel Requirements: Minimal to extensive travel may be required for project coordination and team expansion efforts.
Preferred Qualifications:
- Advance Degree, master's or higher in related field preferred.
- Familiarity with Quality Management Systems (QMS).
- Experience with Internal Review Board (IRB) processes, USDA, and clinical trials.
- Program management proficiency and experience with project management software such as Jira.
- Ability to provide comprehensive reporting and follow protocols set by executive management.
Equal Opportunity Employer: ViruTech/TLC Millimeter Wave Products Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive and equitable workplace for all employees. We prohibit discrimination and harassment based on race, color, religion, sex, national origin, age, disability, genetic information, veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by applicable law.
Work Environment/Physical Demands:
- WORK ENVIRONMENT: Work is normally performed in an environmentally controlled location, office or laboratory environment. This role may be subject to other conditions or hazardous environments.
- PHYSICAL DEMANDS: Must be capable of performing required tasks while using wide variations of physical effort such as sitting, running, walking, standing, crawling, climbing, or remaining in awkward, sometimes strained, positions for extended periods of time; may be required to lift to 20+ lbs.
What We Offer?
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Innovative and Dynamic Environment: Our company fosters a culture of innovation and creativity, where innovative ideas are encouraged, and collaboration is valued. You will have the opportunity to collaborate with a talented team and contribute to groundbreaking projects.
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Growth and Development Opportunities: We are committed to the professional growth and development of our employees. We offer training programs, mentorship opportunities, and resources to enhance your skills and advance your career within the company.
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Meaningful Work: Our company is dedicated to making a positive impact in the tech industry and the community. By joining our team, you will have the chance to work on meaningful projects that have real-world implications and contribute to improving people's lives.
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Competitive Compensation: We offer a competitive salary package that includes benefits and incentives. At TLC, hard work and dedication is recognized and rewarded.
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Work-Life Balance: We believe in the importance of maintaining a healthy work-life balance. We offer flexible working hours, remote work options, and other initiatives to help you achieve a harmonious integration of work and personal life.
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Supportive and Inclusive Culture: We value diversity and inclusivity. Our company strives to create a supportive and inclusive work environment where everyone feels respected, valued, and empowered to bring their authentic selves to work.
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Comprehensive Benefits: We provide a comprehensive benefits package that includes health insurance, retirement plans, paid time off, sick and safe time, and other wellness programs. We care about the well-being of our employees and offer benefits to support their overall health and happiness.
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Company Perks: We offer additional rewards and incentives to enhance your work experience, such as employee discounts, professional memberships, team-building activities, and more.
At ViruTech, a TLC Millimeter Wave Products Inc (TMPI) company, we believe in investing in our associates' success and providing fulfilling and rewarding work experience. We are dedicated to creating an environment where you can thrive both personally and professionally.
