Quality Engineer

Position Overview

The Quality Engineer supports Project Management and Operations across all phases of the product lifecycle to ensure manufacturing, quality, and support activities comply with ISO 13485, ISO 9001, BRCGS and other applicable regulations and standards. This position provides technical leadership in quality engineering, metrology, risk management, problem solving, process validation, and continuous improvement initiatives.

• Provide hands‑on quality engineering support to Project Management, Operations, Engineering, and Production teams
• Lead and model a proactive approach to quality, risk reduction, and continuous improvement

• Partner with Project Managers to schedule and execute all New Product Introduction (NPI) quality deliverables to meet project timelines
• Participate in design and process development activities, including risk management (FMEA, Hazard Analysis), process validation, test plan development, and documentation reviews
• Increase engagement at development of work cells to understand risks, process capability, and quality needs

• Work with Operations Management and Production Supervisors to drive product quality, support manufacturing issues, and lead structured problem solving on the production floor
• Enhance involvement in root cause investigations and CAPA development; lead, don’t follow
• Support production risk documentation and in process inspection activities

• Develop and conduct product testing, metrology, first article inspections, and final inspections.
• Provide analytical presentations on dimensional reports, statistical studies, DOE, Gauge R&R, Cpk analysis including: interpretation of data, identifying what data demonstrates or does not demonstrate, and recommended next steps or actions taken
• Provide optional tolerance recommendations when reporting Cpk results
• Maintain accuracy, attention to detail, and ensure data integrity

• Support the review, approval, issuing, and control of all documentation on the Production floor, prioritizing the ERP (IQMS database). This includes work instructions, quality specifications, validation reports, engineering specifications, and change notices.
• Maintain and improve quality systems to comply with ISO 13485 and other regulatory bodies

• Lead investigations, root cause analysis, and corrective/preventive action (CAPA) implementation
• Process and evaluate customer complaints and ensure timely resolution.
• Act as one of the champions of the MRB (Material Review Board) team.
• Support risk analysis initiatives including FMEA, Hazard Analysis, and related documentation
• Audits (Internal & External)
• Support and/or lead internal QMS audits along with ISO Management Representative
• Participate in external audits and represent QA in customer audits
• Provide constructive, clear feedback during audits or inspections
• Customer, Supplier & Cross Functional Collaboration
• Communicate professionally with customers, suppliers, third party auditors, and regulatory agencie
• Support supplier audits and supplier quality management activities (e.g., NCMRs, supplier CAPA)
• Collaborate cross functionally to resolve quality issues and drive data based continuous improvements
• Support training employees on procedures, work instructions, and ISO requirements
• Mentor team members on quality standards, analytical techniques, and problem solving
• Demonstrate genuine concern for team members; be approachable and responsive when issues arise
• Exhibit leadership by taking initiative and driving quality initiatives

Prepare KPI reports, analyze and track various department performances to be shared with the organization using ERP database (IQMS).

• Personal core values aligned with Dymotek:
  Dymotegrity, ownership, speaking your mind, and passion for winning
• BA/BS degree in a science or technical discipline or equivalent experience
• Minimum 5 years’ experience in a related field; medical device componentry supply industry strongly preferred
• Strong understanding of…