Venocare is leading the design and development of precision-engineered medical devices for vascular access with the goal of improving the patient and caregiver experience. We are seeking a Senior Quality Engineer to provide hands-on quality engineering support and to help maintain, improve, and execute the Quality Management System in support of regulatory compliance and operational excellence.
This position supports compliance with applicable medical device state, federal, and international standards and regulations, including QMS, Medical Device Regulation, ISO 13485, ISO 14971, and other applicable regulations, standards, and guidelines.
This position supports quality system documentation, design controls, risk management, supplier quality, process validation, complaint investigations, nonconformances, CAPA, and audit readiness activities.
The individual must have hands-on experience supporting and improving quality systems and quality engineering processes in a medical device organization. The individual must possess strong technical writing, problem-solving, statistical analysis, and communication skills, and must be able to work cross-functionally with Engineering, Manufacturing, Regulatory Affairs, suppliers, and management.
Role and Responsibilities
- Support New Product Development, Design Controls, Supply Chain, and continuous improvement of the Quality Management System.
- Provide hands-on quality engineering support for design controls, process characterization, process validation, manufacturing transfer, and product/process changes.
- Support risk management activities in accordance with ISO 14971, including Risk Management Plans, Hazard Analyses, DFMEAs, PFMEAs, AFMEAs, risk evaluations, and Risk Management Reports.
- Apply risk-based decision making to balance compliance, product quality, patient safety, and business objectives.
- Review engineering changes and document quality, validation, and risk management impact assessments, including justification when additional verification or validation is not required.
- Support process characterization and validation activities, including IQ, OQ, PQ, TMV, and CSV, as applicable.
- Develop and review validation protocols and reports, sampling and inspection plans, and objective evidence to support product and process requirements.
- Use statistical techniques and tools, including Minitab or equivalent software, for DOE process capability, , measurement system performance (GR&R), SPC, complaint trending, nonconformance analysis, and quality metric evaluation.
- Lead or support investigations for nonconforming product, deviations, quality events, supplier issues and CAPAs, including root cause analysis, corrective action implementation and effectiveness verification.
- Support complaint handling, failure investigation, post-market surveillance, and MDR/MDV reporting activities, as applicable.
- Lead supplier quality engineering activities, including supplier qualification, supplier monitoring, supplier re-evaluation, supplier audits, SCAR management, quality agreements, and Approved Supplier List maintenance.
- Partner with Engineering, Manufacturing, Supply Chain, and suppliers to improve supplier capability, process controls, yield, defect prevention, and overall supplier performance.
- Review and approve supplier quality documentation, including inspection records, certificates of conformance, validation documentation, change notifications, process changes, and corrective actions.
- Participate in internal audits, supplier audits, regulatory inspections, and notified body audits; support preparation of audit responses, remediation activities, and objective evidence.
- Support development, revision, and implementation of quality procedures, work instructions, forms, specifications, training materials, and quality system improvements.
- Support incoming, in-process, and final inspection activities by ensuring inspection methods, acceptance criteria, sampling plans, and records are adequate, effective and compliant.
- Monitor quality metrics and support Management Review inputs, including CAPA, complaints, nonconformances, supplier performance, audit results, and process/product performance.
- Collaborate with Engineering, Manufacturing, Supply Chain, Regulatory Affairs, suppliers, and consultants to resolve quality issues and support business objectives.
- Provide training and guidance to personnel on quality system procedures, quality engineering tools, Good Documentation Practices, statistical methods, and applicable regulatory requirements.
- Drive continuous improvement initiatives focused on product quality, compliance, process capability, supplier performance, manufacturing efficiency, and operational excellence.
- This is a highly hands-on role requiring routine interaction with manufacturing operations, suppliers, and development teams to identify, troubleshoot, and resolve quality and process issues.
Required Qualifications
- Minimum of 7 years of experience in the medical device industry.
- Minimum of 5 years of experience in quality engineering or quality assurance in a regulated medical device environment
- Working knowledge of 21 CFR Part 820/QSR, ISO 13485, ISO 14971, EU MDR, design controls, production/process controls, complaint handling, CAPA, supplier controls, and risk management.
- Experience with supplier quality engineering, supplier audits, supplier qualification, SCAR management, and supplier performance improvement.
- Experience with process validation, test method validation, statistical sampling, process capability studies, DOE, measurement system analysis (GR&R), SPC, and change control.
- Experience supporting FDA inspections, notified body audits, internal audits, or supplier audits preferred.
- Demonstrated ability to apply risk-based decision making while balancing complaince requirements, product quality, patient safety, and business objectives.
- Strong technical writing, documentation, organization, communication, and cross-functional problem-solving skills.
- Demonstrated ability to work effectively in a fast-paced, growth-stage environment with evolving priorities and limited organization infrastructure.
- Proficiency with Microsoft Office and statistical software such as Minitab.
- Ability and willingness to travel domestically and internationally, including supplier and contract manufacturing locations, up to approximately 25%.
Preferred Qualifications
- Experience with Class II medical devices.
- Experience with vascular access devices, needles, catheters, or other sterile single-use medical devices.
- Experience supporting contract manufacturing organizations and outsourced manufacturing operations.
- Experience with supplier quality engineering and supplier development programs.
- Experience supporting sterilization validation and sterile barrier systems.
- Experience in startup, growth-stage, or rapidly scaling medical device organizations.
Licenses/Certifications
- ASQ Certified Quality Engineer (CQE) preferred.
- ASQ Certified Quality Auditor (CQA) preferred.
Education
- BS in Engineering, Life Sciences, or related scientific/technical discipline required. Master's degree preferred.
