Quality Engineer II

Quality Engineer II (12-month contract // Dexter, MI):

Top 3 Skills Required:

1. Ability to lead structured investigations using quality problem‑solving tools such as 5 Whys, Fishbone diagrams, and fault tree analysis. Skilled in managing nonconformances and driving effective Corrective and Preventive Actions (CAPA) to ensure issues are thoroughly resolved, documented, and prevented from recurring in compliance with quality system requirements.
2. Proficiency in using statistical methods and data analysis tools to monitor process performance, identify trends, and reduce variation. Experience applying statistical process control (SPC), yield analysis, and data‑driven decision making to improve product quality and manufacturing consistency.
3. Strong knowledge of medical device quality systems and regulatory requirements, including FDA Quality System Regulation (21 CFR Part 820), ISO 13485, and internal quality procedures. Ability to support audits, manage documentation, and ensure manufacturing processes and product outputs consistently meet regulatory and client quality standards.

Education Required: Bachelor’s degree in Engineering (Quality, Mechanical, Biomedical, Industrial, or related field)

Years’ Experience Required: Bachelor’s Degree and minimum of 2 years of relevant experience, or advanced degree with a minimum of 1 year of relevant experience (experience in EU MDR remediation or EU MDR compliant devices is highly preferred)

Description: The Quality Engineer II provides quality engineering support for products manufactured at the Dexter, Michigan site within the Cardiovascular Surgery business. This role partners closely with manufacturing, process engineering, operations, and cross‑functional teams to ensure products consistently meet client quality standards, regulatory requirements, and patient safety expectations.

Duties:

• Provide day‑to‑day quality engineering support on the manufacturing floor, partnering with operators, supervisors, and engineers to ensure adherence to procedures and rapid resolution of quality issues.
• Collaborate with manufacturing, operations, and cross‑functional teams to ensure compliance with client Quality System requirements, regulatory standards, and internal procedures.
• Lead and support root cause investigations, NCMRs, and Corrective and Preventive Action (CAPA) activities to ensure timely, thorough, and compliant issue resolution.
• Monitor process performance and yields, using statistical methods and data analysis to identify trends, reduce variation, and drive improvements in product quality.
• Support process validation, equipment qualification, and change control activities for new and existing products and manufacturing processes.
• Develop, implement, and maintain inspection and testing methods to ensure product quality and process consistency.
• Apply quality engineering tools and methodologies to reduce defects, improve yield, and prevent recurrence of quality issues.
• Support complaint investigations and partner with relevant teams to implement effective corrective actions when necessary.
• Participate in preparation for and support of internal and external audits, ensuring readiness and compliance with regulatory and corporate standards.
• Provide coaching and guidance to operators, technicians, and engineers on quality system requirements, good documentation practices, and risk‑based decision making.
• Promote and reinforce a culture of continuous improvement, compliance, accountability, and flawless execution across the Dexter manufacturing value streams.
• Maintain and manage documentation and change records within Agile PLM.

Must Haves:

• Familiar with FDA 21 CFR Part 820, EU 217/745 (EU MDR)
• Familiar with these standards: ISO 13485, ISO 14971
• Experience supporting NCMR, CAPA, and investigation activities
• Preferred experience in DOE (with Minitab)
• Execution of test method validation analysis
• Experience in execution and interpretation of process statistical analysis, including SPC and yield analysis
• Experience in equipment IQ
• Experience in OQ (Operational Qualification) and PQ (Performance Qualification) and/or process validation
• Process Validation Lifecycle from process characterization, operational qualification to performance qualification
• Change control of Medical Devices
• Development of Control Plans
• Creating inspection sampling plans
• Develop Risk Evaluations
• Knowledge of Microsoft Office Applications (Word, Excel, Access, and PowerPoint) and Windows OS

Nice to Haves:

• 1-2 years of Medical Device industry experience
• Developing packaging validation plans