Job Overview This role is a hands-on function that can execute and improves quality processes within Quality and Manufacturing departments leveraging consensus building skills with tactical experience to align and perform within cross functional teams. The Quality Engineer develops, implements, and manages one or more processes at a time, including support of daily part and assembly inspections, nonconformity processing, product disposition, Corrective Action(s), and ensures product quality and process efficiency. The role supports validation, process or product qualification activities, metrology development, calibration, supplier quality, training, complaint handling, nonconformance and corrective actions. Responsibilities include data trending and KPI reporting, root-cause investigations, risk analysis, SOP/work-instruction authoring, training and continuous improvement initiatives to create effective lean processes while meeting

FDA 21 CFR

820 and

ISO 13485

requirements and exceeding customer expectations. Essential Functions 1 ) Lead or contribute to NC/CAPA/Complaint completion: initiate records, perform root cause analysis (5-Why, Fishbone), define containment and corrective actions, verify effectiveness, and trend performance via KPIs. 2 ) Manage assigned projects to schedule; coordinate cross-functional inputs; communicate status, risks, and mitigation plans; ensure on-time completion and adherence to standards. 3 ) Partner or Lead process changes: author change requests, utilize data driven decisions, assess risk and validation impact, coordinate stakeholders, execute implementation plans, and verify effectiveness with KPIs. a) Own process improvement(s): map current state, quantify baselines (cost, yield, CTQ), with objective of maximum ROI. b) Design and implement cost‑effective process changes using Lean/Six Sigma tools (5S, SMED, poka‑yoke, DOE), run pilots, verify with data, and standardize via SOPs and training. c) Develop and implement SPC, in-process and final inspections; maintain product or process ownership, actions, and timelines on assigned quality projects. 4 ) Develop, Lead or own quality processes (e.g., internal audits, supplier quality, nonconformance, Training, CAPA); establish standard work, train personnel, and ensure consistent efficient execution. a) Sustain programs or process health; Monitor, analyze, and take action when KPIs signals occur to improve product or process outputs by executing continuous improvement (CIP/Lean/Six Sigma) to meet or improve QMS, cost, product quality, and delivery targets. 5 ) Develop and maintain procedures, SOPs, work instructions, forms, and inspection plans for quality control/assurance such as but not limited to nonconformance/CAPA, MRB, and maintain audit readiness. 6 ) Maintain calibration and metrology schedules with Equipment Maintenance; ensure calibration frequencies and records for gauges and instruments are met. 7 ) Perform development activities including first article inspections (FAI), defining and validating inspection methods, conducting Gage R&R and other MSA studies, building complete qualification packages (e.g., IQ/OQ/PQ documentation, inspection plans, capability reports), and training inspectors and operators on proper measurement and inspection techniques to ensure consistent, compliant execution. 8 ) Prepare for and participate in internal, supplier, and customer audits; collect and present objective evidence and perform audit follow-up. 9 ) Be accessible to all teams and proactively administer training, coaching, and guidance as needed to ensure consistent, compliant execution across functions. Qualifications Education and Certifications Associate degree in engineering, science, or related field required; Bachelor's preferred Professional certifications a plus: ASQ CQE/CQA/CQM/, Six Sigma Green/Black Belt, QMS lead auditor or CMDA Experience 2+ years in quality engineering or quality control in medical device (21 CFR 820, ISO 13485) or pharmaceutical (21 CFR 210/211) preferred Hands-on experience with NC/CAPA, document control (GDP), cGMP, validation (IQ/OQ/PQ), and SPC/MSA, Supplier Quality, Internal Audit, Training Experience with plastics injection molding quality control and inspection equipment desirable. Knowledge, Skills, and Abilities Working knowledge of process capability (Cp/Cpk), AQL, sampling plans, and

ANSI/ASQ

standards; ability to perform statistical analysis using basic tools (e.g., Excel, Minitab) Proficiency creating SOPs, work instructions, inspection forms, and change requests; strong attention to detail and documentation accuracy Strong critical thinking skills and effective communicator with cross-functional teams and suppliers/customers; robust problem-solving and project coordination skills Ability to lead; this is a Quality Management role operating as either individual contributor or potential for direct supervisory duties. Join us to be part of a passionate team dedicated to delivering exceptional quality through innovative testing strategies!

Benefits:

401(k) Dental insurance Health insurance Health savings account Life insurance Paid time off Vision insurance

Work Location:

In person