Principal Supplier Quality Engineer

Integer•Chaska, MN

About The Position

The Principal Supplier Quality Engineer provides strategic quality guidance in support of Integer’s goals and applies extensive engineering and quality knowledge to complex assignments and projects. As a subject matter authority, this role provides technical guidance and quality leadership across the organization, ensuring customer expectations are met or exceeded and that products and processes comply with applicable quality systems, regulations, and company requirements. The position leads supplier quality activities, including supplier non-conformance management, audits, change notifications, quality agreements, sourced-item qualification, and First Article Inspection. It collaborates with suppliers and cross-functional teams to resolve quality issues, conduct capability studies, apply statistical quality control, monitor supplier KPIs, and maintain complete and accurate quality documentation. The role also supports non-conforming material processes, supplier corrective actions, site quality activities, regulatory inspections, product transfers, and continuous improvement initiatives. It may supervise up to three engineering direct reports and serves as a coach and mentor to other engineers. The role supports Integer’s manufacturing excellence and innovation strategies through site and quality plans, sustained change leadership, standardization, associate engagement, and process optimization. Performance is measured in part through safety, adherence to Integer’s values, defined project goals and milestones, quality metrics, and continuous improvement contributions. Candidates must have at least a bachelor’s degree in engineering or a related technical field and 10 or more years of progressive engineering or technically focused experience. A master’s degree or doctorate is preferred. Relevant regulatory and industry-standard awareness, Microsoft Office knowledge, technical aptitude, communication skills, and the ability to work independently and collaboratively are expected.

Requirements

Bachelor’s degree in engineering or a related technical field.
At least 10 years of progressive engineering and/or technically focused experience.
Awareness of relevant domestic and international regulations and industry standards, such as ISO, QSR, UL, MDD, and TGA.
Knowledge of Microsoft Office.
Ability to work independently and collaboratively with associates and cross-functional teams.
Solid technical aptitude and ability to contribute effectively to a team or produce technical results individually.
Effective written and oral communication skills; candidates outside the United States must demonstrate written and oral English competency.
Ability to maintain a calm demeanor in a high-energy, constantly changing production environment.
Positive, can-do attitude and belief that failure is not an option.

Nice To Haves

Master’s degree or doctorate.
Experience or expertise in supplier quality, including audits, non-conformances, supplier corrective actions, capability studies, statistical quality control, and First Article Inspection.

Responsibilities

Provide strategic quality guidance and technical leadership across Integer.
Apply engineering principles and quality knowledge to complex assignments and projects.
Ensure internal and external customer expectations are met or exceeded.
Identify and evaluate procedures to ensure production of quality product; develop approaches to complex problems and apply engineering concepts to resolve them.
Conduct studies to assess process and measurement-system capability and provide technical guidance to management.
Develop documentation for process improvement and project implementation, and maintain technical liaison with internal and external stakeholders.
Manage supplier non-conformances and liaise with suppliers to ensure issues are adequately addressed.
Manage and conduct supplier audits and track closure of audit findings.
Lead supplier product and process change notifications, as applicable, and manage Supplier Quality Agreements.
Work with suppliers and cross-functional teams to resolve supplier quality problems and support capability studies and statistical quality control, including Cpk, DOE, and hypothesis testing.
Manage sourced-item qualification and ensure required documentation is completed.
Manage the First Article Inspection process.
Monitor supplier-related KPIs, assure compliance with DMR, provide deviation and waiver guidance, and ensure Device History Records are complete and correct.
Review changes to Bills of Materials, Incoming Inspection Plans, drawings, component specifications, FMEAs, and related documents for adequacy and correctness.
Serve as a supplier quality resource for site continuous-improvement projects and support product transfers.
Provide supervision for up to three engineering direct reports, as needed, and coach and mentor other engineers.
Follow Integer’s quality management and production system methodologies to investigate product and process improvement opportunities.
Ensure supplier-caused non-conforming material dispositions follow required procedures and supplier corrective actions are adequate to prevent recurrence.
Lead site SCAR activities, including data and trend analysis, containment, root-cause analysis, and effectiveness verification.
Support and lead internal quality audits, as applicable, and support regulatory and agency inspections, audits, investigations, and inquiries related to supplier quality.
Assure adherence to the QMS, support corrective and preventive action investigations and implementation, and contribute to quality KPIs and the journey to 5 Sigma.
Support manufacturing excellence and innovation strategies, site Hoshin Plans, Quality Plans, Validation Master Plans, quality improvement initiatives, and QA/RA metrics updates.
Lead sustained change, including customer change notifications, and support continuous-improvement activities.
Promote workplace organization and visual controls (5S), Manufacturing Standard Work, robust training and certification, standardized problem solving, behavior-based safety, improvement suggestions, and built-in-quality principles.
Actively support Integer Environmental, Health & Safety programs and adhere to Integer’s values.
Perform other duties as needed and directed by line supervision.