Experienced Quality Engineer - Medical Device Manufacturing Banister Medical - 2.0 Pflugerville, TX Job Details Full-time $105,000 - $135,000 a year 1 day ago Benefits Health insurance Dental insurance 401(k) Paid time off Vision insurance 401(k) matching Life insurance Qualifications Customer communication Supplier corrective action implementation Corrective and preventive actions (CAPA) ISO certification audits Vendor compliance audits Supplier audits Manufacturing facility experience Quality risk management Medical device manufacturing facility experience Technology transfer (scale-up process) Supplier development Regulatory/legal compliance standards in production Biomedical regulatory compliance OEM FDA regulations Audit support Full Job Description Banister Medical is seeking an experienced Quality Engineer to help maintain and strengthen our quality management system. The role entails helping manage relationships with our customers' quality teams, supporting and leading efforts to improve our documentation and internal processes and leading continuous improvement and modernization initiatives, including our transition from a paper-based to digital record-keeping system. This is a meaningful opportunity for someone who wants significant impact in a flat organization. We are actively investing in our quality capabilities and capacity. The quality manager will partner with our existing QA and QC teams to support this growth. The Experienced Quality Engineer will report directly to the General Manager, with additional reporting responsibility to the Quality Director and President. This role includes both managerial and individual contributor responsibilities. Key Responsibilities Quality System and Compliance Maintain and continuously improve our

ISO 13485

quality management system Support FDA regulatory compliance, including 21 CFR Part 820 / QMSR Support, and eventually lead, internal and external audits Help maintain audit readiness; represent Banister Medical in customer audits, corrective action responses, and internal business reviews Report quality performance clearly to the General Manager and management team Digital Transformation and Continuous Improvement Help plan and support implementation of a modern, software-based quality management system to replace or enhance current tools Be the resident expert on quality-related software and tools Evaluate and advance metrology capabilities in our QC lab and on the shop floor Identify, scope, and manage risk-based continuous improvement projects that drive measurable efficiency and quality gains Manufacturing Quality Help drive quality execution on the shop floor, including inspection, in-process controls, and nonconformance resolution Partner with operations teams to prevent defects at the source Oversee supplier quality, incoming inspection, and supplier corrective actions Support Customer Requests for Analysis and Studies Includes cleaning validation, equipment validations, PFMEA reports, capability studies, and other data as requested by customers from time to time CAPA Management Own the CAPA process end-to-end: investigation and root cause determination, coordinate implementation, effectiveness verification, internal management tracking and reporting Lead change control and DHF/DMR review processes Customer and Stakeholder Communication Represent Banister Medical quality in customer audits, corrective action responses, and business reviews Report quality performance clearly to the General Manager and management committee

Qualifications Required:

5+ years of experience in a medical device manufacturing or engineering role

ISO 13485

expertise and working knowledge of 21 CFR Part 820 / QMSR Demonstrated quality audit and CAPA management and implementation experience Working knowledge of risk management per

ISO 14971

Experience managing supplier quality and leading customer, internal, and supplier audits Strong written and verbal communication Experience supporting design transfer and DHF review from OEM customers into production Preferred Experience at a medical device contract manufacturer or component supplier to OEMs Experience leading or participating in quality system or technology implementation projects Familiarity with quality requirements from major medical device OEMs Relevant certifications such as CQE, CQA, Six Sigma Green or Black Belt Lean knowledge and experience Why this role? Strong quality track record. Banister completed an FDA audit in Q4 2025, with zero findings and zero observations. Significant role in a successful, growing medical device manufacturing business Entrepreneurial culture; minimal hierarchy and flat org structure = fast decisions and rapid impact Opportunity to become to the top quality professional in the company with full ownership of the position Active mandate to modernize systems and lead improvement, not just maintain the status quo About Us Banister Medical is an ISO 13485-certified contract manufacturer specializing in the precision machining of orthopedic implants and surgical instruments. Our customers - the world's leading medical device companies - rely on Banister to manufacture their most challenging and complex designs. Based in Pflugerville, Texas, Banister has grown steadily for over 30 years. We combine precision manufacturing with a close-knit team environment and a strong commitment to quality and continuous improvement. As the company grows due to strong demand for our products and continuous investments in people and new equipment, we need to expand our team to help us scale. Visit us at www.banistermedical.com for additional information.

Pay:

$105,000.00 - $135,000.00 per year

Benefits:

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

Work Location:

In person