Manufacturing Quality Leader at Switchback Medical – BROOKLYN PARK, Minnesota

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 person in

this role will be responsible for the NCMR system in Grand Avenue (GAS) and will work with

internal and external teams to solve manufacturing problems. They 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:

 Hands-on problem-solving skills.

 Willingness to spend extensive time on the manufacturing floor.

 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.