Title: Quality Assurance Engineer, Senior
Reports to: Quality Assurance Manager
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
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
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.
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.
* 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
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
* 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.
* 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.
* 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.
* 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
EOE / AA Employer:
Must be authorized to work in the United States.
Please visit our web site for additional information about our