Quality Engineer

Smartvest; New Prague (MN); On-site; USD 70,000 - 118,000; Full time

Benefits offered by this job

Discretionary Time Off

Employee bonus plan

Hybrid/Remote options

Paid parental leaves

Recognition program

Training opportunities

Educational assistance

Well-being on demand

Perks at Work

Health benefits + HSA

401(k) match

Great culture

Job summary

Electromed in New Prague, MN is seeking a Quality Engineer to strengthen supplier quality, incoming quality, complaint handling, and product quality trending. You will partner with suppliers, Operations, Regulatory, Design Assurance, and Document Control to identify, investigate, and resolve quality issues across materials, released product, and field performance.

The role requires a Bachelor’s degree and 2+ years in a hands-on quality role, with knowledge of ISO9001-based systems and FDA 21 CFR

Qualifications

• Bachelor’s degree required.
• 2+ years in a hands-on quality role; medical device manufacturing preferred.
• Experience with ISO9001-based quality systems (ISO13485, AS9100, IATF16949).
• ASQ certs preferred (CQE, CQA, CSQP, CSSGB etc.).
• Knowledge of CAPA, deviation, nonconformance processes.

Responsibilities

• Collaborate with suppliers to resolve root causes of nonconforming material.
• Administer MRB process for disposition of rejected material.
• Manage supplier quality performance metrics and scorecards.
• Lead supplier audits and CAPA activities.
• Process customer complaints per established procedures.
• Assist with data analysis to identify quality trends and risks.
• Support internal/external audits and quality documentation.

Skills

Root cause analysis

CAPA

Statistical methods

Quality systems

Cross-functional communication

Travel (≤10%)

Education

Bachelor’s degree

Tools

ISO13485

Job description

People 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:

• Discretionary Time Off
• Employee bonus plan
• Flexible hybrid/remote work options
• 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:

The Quality Engineer supports Electromed’s supplier quality execution, nonconforming material management, complaint processing, complaint investigation support, and product quality trending activities. This role partners closely with suppliers, Operations, Regulatory, Design Assurance, and Document Control to identify, investigate, and resolve quality issues affecting incoming materials, released product, and field performance. This position is based in New Prague, MN.

Job Outcomes You Must Get:

Supplier Quality / Incoming Quality:

• Collaborate with suppliers to resolve root cause(s) of nonconforming material.
• Administer the MRB (Material Review Board) process for determining disposition of rejected nonconforming material.
• Maintain supplier quality performance metrics and scorecards.
• Lead or participate in periodic re-evaluation and audit of suppliers.
• Support supplier corrective action activities and follow-up, as assigned.
• Analyze incoming quality data and nonconforming material trends to identify recurring issues, risks, and opportunities for improvement.
• Support supplier-related investigations and provide technical input when supplier issues may affect field performance or complaint trends

Product Quality / Complaint Support:

• Process customer complaints in accordance with established complaint handling procedures.
• Review, investigate, analyze, summarize, and report on complaint-related quality issues in partnership with the complaint handling program owner.
• Evaluate complaint information for potential linkage to supplier quality issues, incoming material issues, or manufacturing-related product quality concerns.
• Conduct complaint and product quality trend analysis and elevate significant findings to appropriate stakeholders.
• Participate in root cause investigations, risk evaluations, and corrective action activities arising from complaints and product quality issues.
• Collaborate with post-market members on complaint-related assessments, reportability support, and follow-up activities, as needed.
• Support complaint handling and related records during internal and external audits.

Product Quality / Quality Systems Support:

• Analyze data obtained from nonconforming material activity, complaints, inspection results, or other quality inputs to identify unfavorable trends.
• Collaborate with cross-functional teams to support updates to risk management files, as needed.
• Participate in CAPA, deviation, nonconformance, and quality improvement activities.
• Create or edit QMS work instructions and related controlled quality documentation, as assigned.
• Directly participate in notified body, FDA, and internal audits, as needed.
• Initiate Engineering Change Orders as needed to support quality assurance initiatives.
• Interact with UL to update reports as assigned.

Job Outcomes Requirements:

• Bachelor’s degree from an accredited college or university
• 2+ years of verifiable experience in a hands-on Quality role supporting supplier quality, incoming quality, complaints, nonconformance, or related activities; medical device manufacturing experience preferred
• Experience working within a Quality Management System certified to any of the “ISO9001-based” standards (ISO9001, ISO13485, AS9100, or IATF16949)
• Preferred: ASQ certification including CQE, CRE, CSQP, CQA, CQI, CSSGB, CSSBB, or similar
• Preferred: Working knowledge of ISO14971, ISO13485:2016, and FDA 21 CFR 820
• Knowledge of formal problem-solving methods (for example, six-sigma problem solving tools and methodology)
• General knowledge of basic statistics utilized by Quality Assurance in manufacturing organizations, including (but not limited to):
  • Measures of process capability (for example, Cpk or Ppk)
  • Control Charts for variable data (for example, X-bar & R chart)
  • Conventional measures of dispersion in a normally distributed data set
  • Selecting and applying basic inspection sampling plans
  • Tests for comparison of data sets (for example, T-test or ANOVA)
• Exceptional communication skills
• Ability to manage multiple priorities and drive timely follow-up on assigned quality issues
• Ability to travel <10%

The compensation range for this positionis $70,000 to $118,000 annually with the final agreed upon rate to be based on individual experience, skills, and qualifications.Additional benefits include performance-based incentives, comprehensive health benefits, retirement savings options, paid time off, and opportunities for professional growth and development. Benefits eligibility and offerings may vary based on role and location.

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.