Job Description
Job DescriptionPeople Purpose: Beyond Competitive
It is no longer ok to just be competitive regarding how we treat our people in everything we do. Our leadership team believes wholeheartedly we need to be beyond competitive and cultivate a culture of proud, driven employees who are passionate about the work they do and where they do it. Our leadership strives to unleash unsurpassed potential in every team and individual employed and owns making that happen. Sincere, Simple, Smart.
What makes us Beyond Competitive:
- 6 weeks’ time off annually
- Employee bonus plan
- Full pay maternity, paternity, parental, short-term disability leaves
- Employee driven recognition program
- Access to hundreds of training opportunities
- Company paid educational assistance
- Well-being on demand
- Perks at Work
- Competitive health and welfare plans -HSA company contribution
- 401(k) company match
- Great culture and people!
The Opportunity:
To support our continued growth, Electromed is adding a Quality Technician to our Quality Assurance team. Reporting directly to the Director of Quality Assurance, this is an outstanding opportunity for the right candidate to build experience in a wide variety of QA disciplines, while helping the Electromed team improve the lives of patients by making life’s most important moments possible – one breath at a time.® This is a full-time, Monday through Friday, first-shift position, based on-site in new Prague, Minnesota.
Job Outcomes You Must Get:
Receiving Inspection:
- Perform dimensional inspection of purchased materials based on technical drawings and inspection plans, recording results to create inspection reports. Inspection is performed using basic handheld benchtop gauges and a Vision Measurement Machine (VMM).
- Randomly select samples from incoming lots of purchased materials.
- Contact suppliers directly to address and resolve any issues with Certificates of Conformance and similar required documentation.
- Update receiving inspection plans as needed based on input from Quality Assurance and Engineering.
Measurement & Test Equipment Calibration:
- Monitor the location and calibration status of gauges and test equipment used at Electromed.
- Administer the gauge calibration process, including the shipment of gauges to external service providers.
- When gauges are found to be out of calibration, investigate usage history, determine potential impact, and communicate findings to Quality Engineering.
- Administer Test Method Validation (TMV) studies and collect data for subsequent analysis by Quality Engineering (in some industries this may also be known as Measurement Systems Analysis or MSA).
- Specify and purchase new gauges and equipment and enter them into the calibration system.
- Propose updates and create redlined versions of drawings to facilitate inspection of part features.
- Create and edit basic dimensional inspection programs on Vision Measurement Machine (VMM).
Non-conforming Material:
- Administer the cross-functional Material Review Board (MRB) process, document results, and obtain required approvals.
- Collect non-conforming material data, perform basic analysis of trends, and report results.
- Ensure rejected non-conforming material is properly identified and segregated.
- Lead the containment and sorting of suspected non-conforming material, obtain rework approvals, and document sorting/rework results.
Traceability:
- Maintain required records to ensure lot traceability.
Quality Management Systems (QMS):
- Participate directly or indirectly in external and internal audits.
- Propose and initiate changes to existing QMS Work Instructions to reflect current practice and support continuous improvement.
Periodic Audits:
- Perform periodic audits of Electromed’s Electrostatic Discharge (ESD) controls, traceability system, product test records, or other Quality Assurance and Manufacturing systems.
Other duties as assigned.
Job Outcomes Requirements:
- A minimum combined total of 4 years of education and/or experience in:
- A technical degree program from an accredited college/university or trade school, and/or
- Experience in a manufacturing environment in a technical Quality Assurance related role or an adjacent role such as Engineering Technician.
- Ability to read/interpret mechanical drawings and determine appropriate inspection methods.
- Previous experience using a manufacturing ERP (Enterprise Resource Planning) application such as QAD, Oracle NetSuite, SAP, Epicor, or similar.
- Demonstrated knowledge of basic math required to perform dimensional inspections.
- Exceptional attention to detail and self-driven organizational skills.
- Previous experience using Quality Assurance software applications (for example: Grand Avenue, Arena, Windchill, Qualio, Trackwise, Greenlight Guru, MasterControl, Inspection Xpert, GAGEpack, or similar).
- Proficiency in MS Office Applications.
- Understanding of common document control practices.
- Previous experience using handheld benchtop variable and attribute gauges such as calipers, micrometers, height gauges, and thread/pin/plug/ring gauges.
- Strong professional written and oral communication skills.
Preferred:
- American Society for Quality (ASQ) certification
- Experience in the medical device manufacturing industry
- Working knowledge of ISO13485:2016, and FDA 21 CFR Part 820
- Prior experience programming a Vision Measurement Machine (VMM)
Be You.
Our people celebrate diverse individuals, backgrounds, and thinking. As an equal opportunity
employer this is the absolute most important belief in cultivating our culture and growth together.
Core Values
Customer-Focused. Integrity. Resourceful. Collaborative. Results-Driven.
Electromed develops, manufactures, and markets innovative airway clearance devices that help
people around the world breathe better, stay healthier, and lead active and fulfilling lives.
Making Life’s important moments possible-one breath at a time.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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