Position Summary DescriptionThe Quality Engineer II (QE II) is responsible for independently supporting manufacturing and engineering operations to ensure the manufacture of safe, compliant, and high-quality medical devices. This role maintains and improves quality system effectiveness through ownership of investigations, CAPAs, risk management activities, and validation support, while ensuring compliance with applicable regulatory requirements and corporate policies. The QE II operates with general supervision and increased technical depth compared to entry-level Quality Engineers
Job Description- Ensure compliance with cGMP, FDA QSR, ISO 13485, ISO 9001, MDR/CMDR (as applicable), and internal Quality Management System procedures
- Independently own and close investigations, nonconformances, and CAPAs of moderate complexity, including root cause analysis and effectiveness checks
- Assist or lead nonconforming product activities, including investigations and coordination/management of MRB review and approval
- Review and approve quality records within established authority, including deviations, change controls, validation documentation, and risk management records
- Lead or support process, test method, and equipment validation activities, including protocol execution and report approval
- Execute and lead pFMEA and risk management activities in support of manufacturing and process changes, including pFMEA developments and updates
- Provide quality engineering support to manufacturing operations, including disposition of nonconforming material and process issue resolution
- Support new product introductions (NPI) and transfer activities as the Quality Engineering representative
- Work with project teams to develop DOEs and statistically sound tests for appropriate support of results.
- Apply statistical and risk-based tools such as SPC, sampling plans, and data trending to identify and drive process improvements
- Participate in internal/external audits, supplier audits, and regulatory inspections (FDA, ISO), including preparation and response support
- Assist of lead customer complaint investigations and post-market surveillance activities, as assigned.
- Collaborate cross-functionally with Manufacturing, Engineering, Regulatory Affairs, Supply Chain, and Operations
- Prepare quality data and metrics to support management review and continuous improvement initiatives
- Support corporate Regulatory Affairs by providing information for submissions and Annual Reports.
- Identify and implement opportunities for continuous improvement.
- Position is based on-site
Required Qualifications- Bachelor's degree in Engineering (Biomedical, Mechanical, Chemical, Electrical) or a Life Science discipline (Biology, Chemistry) or related technical field.
- Minimum 3 years of Quality Engineering experience in a regulated manufacturing environment (or 1-2 years with a Master's degree).
- Medical device industry experience.
- Experience applying FDA and ISO quality standards within a regulated medical device environment.
- Experience in Quality Engineering, Quality Assurance, or Quality Compliance within a regulated industry.
- Working knowledge of FDA Quality System Regulations (21 CFR 820), ISO 13485, ISO 9001, cGMP, and risk management principles (ISO 14971).
- Experience owning and managing nonconformances, investigations, CAPAs, and nonconforming product processes.
- Experience supporting change control activities and process, test method, and equipment validations.
- Ability to analyze process and quality data, identify trends, and recommend improvements.
- Knowledge of statistical sampling and analysis; experience with SPC, Minitab, or equivalent statistical tools.
- Proficiency with Quality Management Systems (QMS), ERP systems, databases, and Microsoft Office applications.
- Ability to query databases and generate reports.
- Strong technical aptitude, including the ability to read, interpret, and execute technical documentation and procedures.
- Strong written and verbal communication skills.
- Demonstrated ability to work effectively in cross-functional team environments.
- Ability to follow instructions precisely, identify deviations, and recommend corrective actions.
- Commitment to following company policies and safety procedures.
Preferred Qualifications- Certified Quality Engineer (CQE) certification.
- Experience with TrackWise Digital.
- Cleanroom manufacturing experience.
- Advanced experience supporting manufacturing operations through process monitoring, quality improvement initiatives, and technical problem-solving.
Salary Pay Range:
$71,300.00 - $97,750.00 USD Salary
Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or trainingIn addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensationYour recruiter can share more about the specific salary range for your preferred location during the hiring process.
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences
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