SUMMARY DESCRIPTIONThe Manager, Quality Engineering leads Quality Engineering support for manufacturing, product development, process improvement, validation, risk management, and technical issue resolution. The role ensures that products and processes are developed, validated, transferred, maintained, and improved in compliance with company procedures and applicable regulatory requirements. The Manager provides Quality Engineering partnership and technical expertise for nonconformances, CAPAs, customer complaints, and other cross-functional quality activities.
SUPERVISION RECEIVED Under direct supervision of the Director, Quality Operations, with collaboration with site leadership to establish project objectives and priorities.
SUPERVISION EXERCISED Works independently with minimal supervision and supervises a staff of quality engineers and support staff.
DISCRETION & LATITUDE The Manager, Quality Engineering assesses technical and quality data, establishes engineering priorities, provides technical direction to staff, and escalates significant product, process, compliance, and business risks to management for review.
ESSENTIAL DUTIES AND RESPONSIBILITIES To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Primary responsibilities are to:
- Maintain a thorough understanding of applicable requirements and standards, including FDA GMPs, ISO 9001, ISO 14971, ISO 13485, MDSAP company policies and procedures, validation guidance, and other applicable standards.
- Lead Quality Engineering support for Manufacturing, QA/QC, Regulatory Compliance, Product Development, and other business partners.
- Build and develop a strong team of quality engineers through effective hiring, onboarding, coaching, goal setting, retention, and resource planning.
- Participate in the development and implementation of new processes, process and product transfers, continuous improvement activities, and technical issue resolution.
- Provide guidance on verification and validation plans, process validation and revalidation, test methods, sampling methods and plans, test equipment acquisition, sterilization validation and revalidation, and Process Excellence initiatives.
- Lead or support technical investigations involving product, process, equipment, test method, validation, and manufacturing performance issues.
- Provide Quality Engineering partnership and technical expertise for nonconformances, CAPAs, and customer complaint investigations, including technical assessment, investigation support, risk evaluation, root-cause analysis, action development, and effectiveness evaluations, as applicable.
- Ensure Quality Engineering deliverables and assigned technical investigation activities are complete, accurate, scientifically sound, appropriately documented, and completed within established timelines.
- Lead and document product and process risk-management activities within the Quality Engineering scope, including risk assessments supporting investigations, process changes, validation, transfers, and issue resolution.
- Analyze engineering and manufacturing data, including process capability, statistical process control, validation results, recurring technical issues, and other relevant quality indicators, to identify opportunities for improvement and risk reduction.
- Participate in the compilation and review of technical documentation supporting domestic and international regulatory submissions, inspections, and audits.
- Participate in external and internal audits, including FDA, Notified Body, customer, and corporate audits, by providing Quality Engineering subject-matter expertise and objective evidence.
- Benchmark regulatory and industry practices and participate in professional forums or committees that influence engineering, validation, risk-management, and quality practices.
- Perform other related duties as necessary.
DESIRED MINIMUM QUALIFICATIONS - Education: BS degree in Engineering or Science; ASQ/CQE certification strongly preferred.
- Experience: 7-10 years of quality assurance engineering, manufacturing engineering, validation, reliability, or related experience supporting manufacturing; product-development experience is a plus.
- Excellent written and verbal communication skills.
- Working knowledge of GMP, Quality Engineering, validation, risk management, and applicable Quality System requirements; medical-device industry experience strongly preferred.
- Demonstrated knowledge of FDA GMPs, ISO 9001, ISO 14971, ISO 13485, company policies and procedures, validation guidance, and other applicable standards.
- Demonstrated ability to think strategically, lead technical teams, manage priorities, and collaborate across functions.
TOOLS AND EQUIPMENT USED Ability to use a computer, telephone, and general office equipment. Strong computer skills and familiarity with Microsoft Office applications are required.
Salary Pay Range:
$109,250.00 - $149,500.00 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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