Operations Quality Engineer Manager

About Us:

We are a contract manufacturer offering medical device prototyping, development, and manufacturing. Our primary capabilities are balloon catheters, delivery systems, reinforced and steerable catheters, nitinol components, and biomedical textiles.

Summary:

Oversee and manage all Operations Quality Engineering personnel and processes. The Operations Quality Engineer Manager will be responsible for the NCMR system in Grand Avenue (GAS) and will work with internal and external teams to solve manufacturing problems. The Manager will also be working with suppliers on any problems with supplied parts and conducting supplier audits as needed.

Essential Duties and Responsibilities (but are not limited to):

• Manage, mentor, and coach Operations Quality Engineers on quality standards and best practices. Provide job direction, training and conduct performance reviews.
• Manage the NCMR system in Grand Avenue (GAS) including tracking and trending NCMRs to identify CAPAs as required. Communicate nonconformance issues across all levels of the organization
• Lead CAPA Investigations and implementation of corrective actions to ensure thorough investigation, effectiveness and timely completion.
• Manage manufacturing quality problems through systematic root cause analysis, data-driven decision making, and cross-functional collaboration.
• Create Master Validation Plans for processes transferring to manufacturing. Support process validation activities including protocol development, execution oversight and report approval.
• Identify supplier issues and drives improvements to reduce incoming non-conformances. Manage supplier quality relationships and facilitate corrective action implementation as needed
• Conduct supplier and process audits as needed to ensure compliance with quality standards and regulatory requirements.
• Implement Statistical Process Controls (SPC) on production lines to monitor process capabilities and drive continuous improvement.
• Develop and implement error-proofing mechanisms (poka-yokes) to prevent defects and improve manufacturing processes.
• Support risk management activities in accordance with ISO 14971, including participation in pFMEA creation and updates.
• Maintain and oversee content of the Device Master Record (DMR) to ensure accuracy and compliance. Audit Design History File (DHF) for completeness and accuracy.
• Support internal and external audits, including client audits conducted on the Operations level. Participate and lead response to audit findings.

Technical Skills:

• Extensive expertise in manufacturing operations and quality systems in a medical device environment.
• Deep understanding of ISO 13485 and FDA QSR requirements including design controls, risk management, and process validation.
• ISO 13485 Lead Auditor certification. Experience conducting supplier audits and process audits.
• Experience in eQMS systems, preferably GAS.
• Experience with error proofing techniques (poka-yokes) and their implementation in manufacturing environments.
• Root Cause Analysis (RCA) including, ability to define problems, collect data, establish facts and draw valid conclusions.
• Highly proficient with MS Office (Word, Excel, Access and PowerPoint), internet and e-mail systems. Solid understanding of software capabilities and business applications.
• Ability to accurately prioritize and execute with minimal direction.
• Ability to interpret and understand drawing specifications, tolerances, procedures for inspection and the application of sampling plans.
• Familiar with the ability to use inspection devices such as pin gauges, micrometers, calipers, pressure gauges, rules and microscopes.
• Broad knowledge of theory and principles of statistics and statistical process control.
• Excellent communication skills (written and verbal).

Conceptual Skills:

• Ability to lead cross functional teams and influence without authority.
• Creative problem solver coupled with good judgment.
• Independent work skills.
• High attention to detail and accuracy.
• Ability to manage, prioritize and execute multiple tasks.
• Positive, flexible outlook.
• Strong interpersonal communication skills with the ability to effectively communicate across all levels.

Education/Experience:

• Bachelor Degree in engineering or a related STEM field is preferred. Equivalent work experience or MBA may substitute.
• Minimum of 8+ years experience in Quality Engineering Operations in a medical device manufacturing/process development environment.
• Minimum of 3+ years leading a team of engineers and/or technicians.
• Experience in process design development and product development team environment.

Experience in a manufacturing team environment. Catheter assembly preferred.