Principal Supplier Quality Engineer

Integer Holdings Corporation • Chaska, MN

8d • $143,500 - $210,540

About The Position

The Principal Supplier Quality Engineer provides strategic quality guidance in support of Integer’s goals and serves as a subject matter authority across the organization. The role applies extensive engineering and quality expertise to complex assignments, project leadership, technical problem-solving, process and measurement-system capability studies, and quality improvement. It works to meet or exceed internal and external customer expectations and follows Integer’s quality, safety, environmental, security, FDA, and other regulatory requirements.

The position manages supplier quality processes, including supplier non-conformances, audits and findings, product and process change notifications, Quality Agreements, sourced-item qualification, and First Article Inspection. It partners with suppliers and internal teams to resolve quality problems, conduct capability studies, apply statistical quality methods, monitor KPIs, maintain compliant records, review technical documentation changes, support site improvement projects, and assist with product transfers. The role also supports non-conforming material disposition, supplier corrective actions and SCARs, internal audits, and regulatory inspections and inquiries.

The engineer may supervise up to three engineering direct reports and serves as a coach and mentor to other engineers. The role contributes to Integer’s manufacturing excellence and innovation strategies through site and quality plans, sustained change, standardization, associate engagement, and process optimization. Performance is measured in part through safety, adherence to company values, defined goals and milestones, quality metrics, and continuous improvement contributions.

Requirements

• 10+ years of progressive engineering and/or technically focused experience.
• Bachelor’s degree at minimum in an engineering or related technical field.
• Awareness of relevant domestic and international regulations and industry standards, such as ISO, QSR, UL, MDD, and TGA.
• Good 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.
• Competency in written and oral communication.
• For roles outside the United States, competency in written and oral English communication.
• 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.

Responsibilities

• Apply engineering principles and practices to broad assignments and related technical fields.
• Ensure internal and external customer expectations are met or exceeded and evaluate procedures for producing quality products.
• Develop approaches to complex problems and advance technology beyond previously achieved levels.
• Resolve acute or chronic problems using engineering concepts.
• Conduct process and measurement-system capability studies and provide technical guidance to management.
• Develop appropriate documentation for process improvement and project implementation.
• Maintain technical liaison with individuals and units within or outside the organization, acting independently on technical matters.
• 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 suppliers’ product and process change notification system, as applicable.
• Lead the Supplier Quality Agreement management process with suppliers.
• Work with suppliers, management, Supply Chain, engineers, and manufacturing associates to resolve supplier quality problems.
• Assist with 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 complete and correct Device History Records.
• Review changes to Bills of Materials, Incoming Inspection Plans, drawings, component specifications, FMEAs, and related documents for adequacy and correctness.
• Serve as the supplier quality resource for site continuous improvement projects and support product transfers.
• May supervise up to three engineering direct reports and coach and mentor other engineers.
• Perform technical project work using Integer quality management and production system methodologies to identify product and process improvement opportunities.
• Ensure supplier-caused non-conforming material dispositions follow required procedures and supplier corrective actions adequately prevent recurrence.
• Lead site SCAR activities, including data and trend analysis, bounding and containment, root cause analysis, and effectiveness verification.
• Support and lead internal quality audit activities, as applicable.
• 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 KPI attainment and the journey to 5 Sigma.
• Support strategy alignment through site Hoshin Plans, Quality Plans, Validation Master Plans, quality improvement imperatives, and regular QA RA metric updates.
• Lead sustained change, including customer change notifications and continuous improvement activities.
• Support workplace organization and visual controls (5S), Manufacturing Standard Work, and training and certification programs where applicable.
• Promote associate engagement through standardized problem-solving methods, behavior-based safety programs, and improvement idea and suggestion systems.
• Support systems and process optimization through built-in-quality principles.
• Actively support Integer Environmental, Health & Safety programs, adhere to Integer Values, meet defined goals and milestones, and generate and support continuous improvement suggestions.
• Perform other duties as needed and as directed by line supervision.

Benefits

• Base salary and a cash-based incentive program.
• Medical insurance.
• Dental insurance.
• Vision insurance.
• Disability insurance.
• Life insurance.
• Adoption benefits.
• Parental leave available after one year.
• Optional employee-paid supplemental life insurance, critical illness, hospital indemnity, and accident insurance.
• 401(k) plan with company matching contributions, with immediate eligibility.
• 80 hours (10 days) of company-designated holidays per year.
• Annual allotment of paid time off.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal