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Quality Assurance Engineer, Senior

Company: Minnetronix
Location: saint paul
Posted on: May 3, 2021

Job Description:

Title: Quality Assurance Engineer, Senior

Reports to: Quality Assurance Manager

About Us:

Minnetronix provides award-winning product design, development and manufacturing services to the medical device and life science marketplaces. Minnetronix successfully incorporates custom electronic, mechanical and software engineering into finished Class II & III devices and systems such as cardiovascular and monitoring systems, therapeutic and implantable devices, and diagnostic instruments. Minnetronix is ISO 13485 certified and is an FDA registered manufacturer .

Our company offers excellent benefits including medical, dental, life and disability insurances, 401k plan, paid time off, and tuition reimbursement among others. Additionally, our company has a fun, flexible and challenging work environment that fosters innovation and growth for all employees.

Engineers are encouraged to be creative and innovative, while at the same time are expected to learn, improve, and champion our structured processes. In addition, our engineers are expected to contribute to our team while enhancing their own technical competence and leadership skills while continually increasing their responsibilities.

Job Summary:

The Senior Quality Engineer supports the transfer of products from design to manufacturing and serves as a member of our production support team for complex electronic and software based medical devices. This role supports our production quality system processes, corporate quality initiatives, improvement activities, and customer quality relationship for assigned manufacturing lines. For design transfer projects, this role will own and support design transfer deliverables, including development of appropriate process control and inspection methodologies. For production released products, this role will manage quality control strategies, disposition processes, continuous improvement initiatives, and change management.

Essential Duties and Responsibilities:

* Lead the activities and manage the effectiveness of business processes (i.e. NMR, Complaint Investigations, CAPA, Process Qualification & Validation, Process Control & Monitoring, Engineering Change Control, etc) directly supporting the production business and manufacturing lines. * Lead the activities and manage the effectiveness of design transfer processes (i.e. Risk Management, Process Qualification & Validation, Design of Experiments, Process Control, Material Control, Final Acceptance Testing, Production Engineering Change Orders, etc) * Serve as quality review and approval authority for assigned product lines in support of the manufacturing cell. * Serve as the Quality point of contact with production customer organizations. Own the effectiveness of the quality relationship with assigned customers. * Support the supplier management process including selection, approval and problem resolution to ensure parts and components delivered meet specifications. * Support the Quality System audit program, including leading audits as required.

Required Qualifications:

Bachelor's degree in engineering discipline

* Minimum 6 years' experience to include: * Minimum 4 years' experience in quality support role for manufacturing. * Minimum 2 years' experience in FDA regulated medical device industry.

* Demonstrated experience in predictive engineering and process control methods. * Demonstrated experience in lean manufacturing practices and team facilitation. * Demonstrated experience in problem solving and root cause analysis methods. * Demonstrated experience in process qualification and validation. * Demonstrated experience in process risk management methods. * Demonstrated experience in poka-yoke strategies in production. * High proficiency in use of standard electronic business tools: Outlook, Word, PowerPoint, Excel, ERP/MRP systems. * Experience in use of statistical analysis software. * Effective communication skills of technical issues to various functional levels, ability to make data driven decisions, passionate for change and continuous improvement, and embodying a strong sense of urgency.

Preferred Qualifications:

* Lean Six Sigma Certified Green/Black belt. * Lead Quality Auditor training/certification (ISO 13485 and/or FDA QSR) * Professional training/certification in DMAIC and the use of A3's * Direct experience in the manual assembly production processes and associated techniques for human factors controls. * Direct experience in developing control plans during design transfer phases of projects. * Professional training/certification in Design for Manufacturing

At Minnetronix Medical, cultural fit is as critical to us as the skills and capabilities new employees bring to our team. So, we hire for both attitude and aptitude.

Our?cultural values?are the pillars of our company and define how we promise to show up: Unity, Courage, Humility, and Drive. Our?cultural beliefs?are the key behaviors we have identified as the most critical to advance our culture, our team and our company:

Row Together

* I reach across boundaries to pursue the best outcomes for patients, customers and the company. * I am passionate about producing products that help people. * I collaborate with others, internally and externally, to drive the best solutions across the full product life cycle: how it works, how it's built, how it's controlled. * I value diversity of thought and perspectives.

Create Tomorrow

* I consistently challenge my thinking to achieve our company's Key Results. * I demonstrate a positive "can do" attitude. * I project confidence in the process of design/development. * I embrace changes and challenges. I am creative and innovative in my approach. * I challenge the status quo and continuously searches for the best solutions.

Own It

* I own problem resolution, especially when it's hard. * I am energized by challenges and the work to solve them. * I take ownership/accountability in solving problems and delivering results. * I have a proven track record of designing and transferring high-performing products to production.

Courageous Dialogue

* I seek new perspective from others to improve both thinking and doing. * I lead and operate with humility; demonstrating strong emotional intelligence. * I build trust in a variety of relationships. * I successfully use both strong written and oral communication skills. * I communicate effectively with audiences across all levels, both internally and externally.

Minnetronix, Inc. 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.

EOE / AA Employer:

Must be authorized to work in the United States.

Please visit our web site for additional information about our company:

Keywords: Minnetronix, St. Paul , Quality Assurance Engineer, Senior, Other , saint paul, Minnesota

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