Quality Engineer

About the role

This role focuses on ensuring the consistent quality performance of products and processes by working closely with Operations and cross-functional business partners. The Quality Engineer manages non-conformances and CAPA activities, supports supplier quality and change management, and drives process improvements and validations in a live production environment. The position requires a balance of supplier quality and product/manufacturing quality experience, strong root cause analysis skills, and the ability to operate effectively in a fast-paced, highly regulated setting.

Responsibilities

• Work closely with Operations and other business functions to ensure the quality performance of products and processes.
• Collaborate with internal cross-functional teams and suppliers to address top quality issues and drive effective resolutions.
• Own identified internal and supplier-driven Non-Conformances (NC) and Corrective Action Preventive Action (CAPA) records, ensuring timely processing and closure within the electronic quality management system (e.g., TrackWise).
• Support the execution and analysis of manufacturing-related complaint investigations and product field actions, ensuring robust documentation and follow-up.
• Investigate internal non-conforming product within the Material Review Board (MRB) process and issue NCs as appropriate, including disposition of non-conforming materials.
• Communicate and collaborate with suppliers regarding non-conformances and escalate Supplier Corrective Action Requests (SCAR) as required.
• Execute and manage Supplier Initiated Change Requests (SICRs), engaging cross-functional teams for technical assessment, risk evaluation, and approval.
• Support manufacturing transfers to and from other plants or facilities by executing appropriate quality activities and ensuring compliance with applicable procedures.
• Collaborate with stakeholders to identify and implement opportunities for supplier part certification to improve incoming quality and efficiency.
• Engage in the development and improvement of internal manufacturing and distribution processes for existing products, focusing on quality, robustness, and efficiency.
• Perform critical assessments and qualifications of internal and supplier-proposed changes, including conducting or supporting Production Part Approval Process (PPAP) activities for supplier changes.
• Participate in and, when appropriate, lead the creation, revision, and review of new or modified procedures related to quality, manufacturing, and supplier management.
• Support the development and review of process and equipment validation and qualification activities, as well as Measurement System Analysis (MSA) for internal processes.
• Maintain key performance indicators (KPIs) for monitoring process and product quality, perform data analysis, interpret trends, and implement appropriate corrective or preventive actions.
• Support live production issues in real time, helping to keep operations moving while maintaining compliance and product quality.
• Lead or actively contribute to discussions with stakeholders to explain issues, proposed fixes, and resolution plans in a clear and structured manner.
• Work independently and as part of cross-functional teams, taking ownership of issues and driving actions to closure.
• Perform other related duties as assigned to support overall quality and operational objectives.

Essential Skills

• Balanced experience in both supplier quality and product/manufacturing quality, with approximately a 50/50 focus.
• Strong experience in root cause analysis, including structured problem-solving methods to identify, contain, and eliminate quality issues.
• Hands-on experience managing Non-Conformances (NC) and Corrective Action Preventive Action (CAPA) activities from initiation through closure.
• Demonstrated experience with validation activities for both processes and equipment in a production or regulated environment.
• Experience handling supplier quality issues and change management, including supplier-initiated changes and internal change orders.
• Experience managing internal manufacturing issues and changes, ensuring quality and compliance during process updates or transfers.
• Proficiency with documentation and quality system work, including authoring, reviewing, and maintaining controlled documents.
• Ability to support live production issues, pivot quickly, and keep operations moving while maintaining quality standards.
• Comfort working in a high-pressure, time-sensitive environment with frequent changes and shifting priorities.
• Ability to work independently as well as collaboratively across teams, taking ownership and driving actions to completion.
• Strong communication skills, with the ability to clearly explain issues, root causes, and resolution plans to diverse stakeholders.
• Comfort leading discussions and influencing stakeholders, including manufacturing, engineering, quality, regulatory, compliance, and suppliers.
• Naturally curious and investigative mindset, with a strong problem-solving orientation.
• Demonstrated ability to take ownership, drive action, and lead conversations to resolution.
• Experience working in or closely with manufacturing environments, particularly on or near the production floor.
• Background in medical devices or another highly regulated industry.
• Engineering or science degree or equivalent technical education.
• Experience collaborating with manufacturing, engineering, quality, regulatory, and compliance functions.

Additional Skills & Qualifications

• Experience with Production Part Approval Process (PPAP) for supplier or internal changes.
• Familiarity with quality tools and methods such as Failure Mode and Effects Analysis (FMEA), Process FMEA (PFMEA), and control plans.
• Knowledge of process flow mapping and understanding of how process changes impact quality and compliance.
• Experience using TrackWise or similar electronic quality management systems.
• Experience with MasterControl or similar document and quality management systems.
• Experience with SAP or comparable enterprise resource planning (ERP) systems.
• Prior experience in a medical device or other regulated industry, with understanding of regulatory expectations and compliance requirements.
• Manufacturing floor experience, including frequent interaction with operators, engineers, and quality teams.
• Strong stakeholder management skills, including the ability to build relationships and collaborate effectively with internal and external partners.
• Clear, concise communication style, particularly when explaining complex issues and proposed fixes to non-technical audiences.
• Ability to remain calm and effective in stressful, time-sensitive situations while maintaining a focus on quality and compliance.

Pay

The pay range for this position is $64.52 – $70.81/hr. Individual compensation offered within this range will depend on qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Schedule

This role follows a hybrid schedule with four days on site and one remote day per week. Typical working hours start between 7:00 a.m. and 8:00 a.m., with a standard 40-hour workweek. The workday can be fluid, with frequent changes and the need to respond quickly to live production issues and evolving priorities.