Senior Manager, Quality Engineering

What We Offer

Job Summary

The Senior Quality Engineering Manager provides strategic and technical leadership for the Quality Engineering function within a regulated medical device manufacturing environment. This role is responsible for leading a team of Quality Engineers and driving excellence in product and process quality from design through commercialization. The manager ensures all quality systems comply with ISO 13485 FDA 21 CFR and EU MDR requirements while partnering closely with Operations Engineering R&D and Supply Chain to align quality objectives with business goals. This role will lead process improvement initiatives strengthen quality management systems and champion a culture of continuous improvement and collaboration. This position plays a key role in risk reduction compliance assurance and delivery of safe effective and high-quality products that meet or exceed customer expectations.

Essential Duties and Responsibilities

• Lead and mentor a team of Quality Engineers to ensure consistent delivery of high-quality products that meet or exceed customer expectations.
• Foster professional growth through coaching targeted training performance feedback and individual development plans.
• Recruit develop and lead high-performing Quality Engineering talent; build organizational capability through mentorship performance management and succession planning.
• Serve as a quality champion across the organization influencing design engineering and manufacturing decisions to embed quality principles from concept through commercialization.
• Align Quality Engineering priorities with operational and business objectives to achieve strategic alignment.
• Develop strong cross-functional partnerships with Design Quality Engineering R&D Manufacturing Operations Corporate Quality and Supply Chain teams to drive alignment and performance.
• Collaborate with customers to maintain compliance and strengthen quality partnerships
• Ensure Quality Systems are compliant with regulatory and company standards (ISOCFR EU MDR).
• Review approve or author quality documentation including investigations SOPs validation protocols/reports and device master records.
• Evaluate design and optimize production and process control strategies to achieve both quality and plant objectives.
• Serve as a Subject Matter Expert during internal and external audits and contribute to audit readiness and execution.
• Drive continuous improvement initiatives through process optimization data analytics and adoption of quality tools and technologies.
• Develop and implement strategies to control costs mitigate risks and enhance productivity while maintaining compliance.
• Evaluate and implement changes to continuously improve the Quality Management System (QMS) ensuring scalability and effectiveness.
• Define monitor and analyze key Quality metrics (KPIs) to assess performance compliance and identify improvement opportunities.
• Keep current with emerging technologies regulations and best practices to ensure proactive compliance and innovation in quality systems.
• Perform other related duties as assigned in support of quality operational and business objectives

Education

• Bachelors Degree in a related field such as Engineering or Science required.
• Masters Degree with an emphasis in Engineering Science or Business preferred.

Work Experience

• Minimum 10 years of related experience in the Medical Device/GMP industry required.
• Minimum 5 years of People Management experience preferred.
• Minimum 5 years of experience working with validations pFMEA Risk Management Root Cause Methodology CAPA MSA Lean Manufacturing Six Sigma auditing processes and project management preferred.
• Knowledge of Medical Device Regulatory Requirements and MD Standards: 21 CFR Part 820 EU/MDR ISO 13485 ISO 14791 GMPs GDP.

Preferred Knowledge Skills and Abilities

• Organizational skills will enable planning prioritization and achievement of goals especially of importance for the successful execution of customer visits and business development related activities.
• Strong knowledge and experience in Quality Systems in Medical Devices/Pharmaceuticals
• Ability to work effectively with teams and manage multiple tasks to meet deadlines.
• Demonstrated people skills specific to team building problem solving and conflict resolution.
• Project management experience and ability to present projects progress to upper management.
• Excellent presentation writing verbal computer interpersonal and communication skills.
• Ability to adapt to frequent changes unexpected events and still yield an effective outcome.
• Manages competing demands makes timely and sound decisions even under conditions of risk.
• Accepts feedback from others ability to engender enthusiasm motivate peers and subordinates and teambuilding.
• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description.
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
• Able to comply with the companys safety policy at all times.
• Able to comply with the companys quality policy at all times. #LI-NJ1 #LI-Onsite

License and Certifications

• Lean Six Sigma Black Belt certification. preferred
• CQA/CQE certification. preferred

Travel Requirements

Physical Requirements