Quality Engineer II

Position summary

The Quality Engineer II is primarily responsible for supporting sustaining quality activities for existing manufacturing processes and products, ensuring continued compliance with customer, regulatory, and Quality Management System (QMS) requirements. This role serves as a key quality resource for manufacturing operations, including nonconformance investigations, corrective and preventive actions, process monitoring, risk management, and continuous improvement initiatives.

Additionally, the Quality Engineer II supports New Product Introduction (NPI), product transfers, process validations, and other quality engineering projects as needed based on business priorities. The position works collaboratively with cross-functional teams to maintain and improve product quality, process effectiveness, and compliance within a fast-paced, growing manufacturing environment.

Essential Job Functions

• Serve as the primary quality engineering interface for assigned manufacturing operations, providing ongoing support for product quality, process performance, and issue resolution.
• Lead and/or support nonconformance investigations, root cause analysis, corrective and preventive actions (CAPA), and implementation of appropriate corrective measures.
• Lead and/or support customer complaint investigations, ensuring timely resolution and appropriate documentation.
• Monitor and analyze manufacturing quality data, process performance, and quality trends to identify opportunities for improvement and prevent recurring issues.
• Support the maintenance and improvement of process controls, inspection methods, sampling plans, and acceptance criteria.
• Support manufacturing process changes, equipment changes, and process improvements, including risk assessments, qualification, and revalidation activities as applicable.
• Maintain and update process risk management documentation, including PFMEAs and control plans, in collaboration with cross-functional teams.
• Collaborate with Manufacturing, Engineering, and other departments to resolve quality issues and implement sustainable improvements.
• Identify, recommend, and implement continuous improvement initiatives to enhance product quality, manufacturing performance, and process effectiveness.
• Support and/or lead assigned NPI and product transfer activities as needed, ensuring compliance with applicable customer, regulatory, and internal requirements.
• Develop, execute, and/or support process validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), as applicable.
• Participate in the development and review of inspection strategies, sampling plans, acceptance criteria, PFMEAs, and control plans for new or transferred products.
• Collaborate with cross-functional teams to support production readiness and successful transition of new or transferred products into routine manufacturing.
• Contribute to the implementation, maintenance, and continuous improvement of the Quality Management System (QMS).
• Support internal, customer, and regulatory audits, including audit preparation, execution, and follow-up activities.
• Participate in supplier quality activities, including supplier investigations, qualification, and performance monitoring, as required.
• Support environmental monitoring, calibration systems, document control, and other quality system processes, as applicable.
• Ensure compliance with applicable regulatory requirements, customer specifications, and internal quality standards.
• Support the implementation, maintenance, and effective use of quality-related business systems.
• Promote a culture of quality, compliance, and continuous improvement across the organization.
• Provide technical guidance and support to quality personnel and cross-functional teams, as appropriate.
• Participate in cross-functional projects, providing quality engineering expertise and recommendations.
• Collaborate with sister companies and other business units to share and implement applicable best practices.
• Read, understand, and follow applicable procedures, work instructions, and standard work.
• Perform other quality engineering responsibilities as assigned, based on business needs and priorities.

Minimum Requirements, Education & Experience (incl. KSA’s and certifications)

• Bachelor’s degree in Engineering or related technical field (Mechanical, Industrial, Biomedical, or similar)
• 4+ years of experience in quality engineering within the medical device or regulated manufacturing industry.
• Bilingual English Spanish, advanced level (B2+ minimum)
• Demonstrated experience in:
• Manufacturing quality and sustaining engineering activities.
• Nonconformance investigations, root cause analysis, and CAPA.
• Process monitoring, quality data analysis, and continuous improvement.
• Process validation (IQ/OQ/PQ).
• Risk management tools, including PFMEA and control plans.
• Strong knowledge of:
• ISO 13485 and FDA 21 CFR 820 requirements
• Statistical methods and quality tools
• Inspection methods, sampling plans, and manufacturing process controls.
• Experience in different manufacturing environments (machining, molding, assembly, or similar)
• Strong problem-solving, communication, and leadership skills
• Ability to work effectively in a startup or fast-paced environment
• Proficiency in Microsoft Office tools
• Clear and effective verbal and written communication skills

Desirable Criteria & Qualifications

• Experience supporting New Product Introduction (NPI) and product transfer activities.
• Experience in supplier quality and internal or external audit activities.
• ASQ certification (e.g., CQE, CQA)
• ISO13485 Internal Auditor certification.
• Experience implementing or improving QMS systems in a startup or scaling environment
• Familiarity with ERP/MES systems (e.g., Epicor) and data analysis tools
• Experience with manufacturing process changes, equipment qualification, and process revalidation.

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