Principal Supplier Quality Engineer

Integer Holdings Corporation; Chaska (MN); On-site; USD 144,000 - 211,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Disability insurance

Life insurance

Adoption benefits

401(k) with company match

Job summary

Integer Holdings Corporation is seeking a Senior Supplier Quality professional to provide strategic quality guidance and manage supplier quality activities. The role emphasizes audits, change notifications, and collaboration across suppliers, engineering, and manufacturing teams to ensure quality products.

With a background in engineering and extensive knowledge of relevant standards, you will drive capability studies and defect reduction initiatives within a global manufacturing context.

Qualifications

• Bachelor’s degree in engineering or related field.
• Experience with ISO, QSR, UL, MDD, TGA and related standards is preferred.
• Demonstrated ability to lead supplier quality activities and improve processes.

Responsibilities

• Manage supplier non-conformances and liaise with suppliers to close issues.
• Lead supplier audits and track audit findings closures.
• Lead supplier change notification and supplier quality agreement processes.
• Collaborate with suppliers, management, supply chain, and engineering teams to resolve quality problems.
• Support capability studies and apply statistical quality control (Cpk, DOE, hypothesis testing).
• Oversee item qualification, First Article Inspection, and documentation.
• Monitor supplier KPIs and ensure compliance with DMR, maintain Device History Records.
• Review changes to BOMs, inspection plans, drawings, specs, and FMEAs.

Skills

Engineering principles

Quality guidance

Supplier quality

Audit management

Problem solving

Documentation

Education

Bachelor's degree in engineering

Master’s or Doctorate (preferred)

Tools

Microsoft Office

Job description

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long‑term success. At Integer, our values are embedded in everything we do. Customer We focus on our customers’ success Innovation We create better solutions Collaboration We create success together Inclusion We always interact with others respectfully Candor We are open and honest with one another Integrity We do the right things and do things right Who are we? Integer is a global organization providing innovative, high-quality technologies and manufacturing to Medical Device OEM’s (original equipment manufacturers) to enhance the lives of patients worldwide. We are guided by our six Values, including focus on Customers, Innovation, Collaboration, Inclusion, Candor, and Integrity. Working at Integer means you are part of a team passionately pursuing excellence in all that we do and always reaching for the next great achievement.

What you’ll do in this role:

The primary purpose of this position is to provide strategic quality guidance that supports Integer’s goals.

The following are the expectations for this role:

• Apply intensive and diversified knowledge of engineering principles and practices in broad areas of assignments and related fields.
• Ensure Integer internal and external customer expectations are met or exceeded.
• Identifies and evaluates procedures to ensure the production of quality product.
• Develop new and unique approaches to complex problems and can advance technology beyond previous achieved levels.
• Apply engineering concepts to resolve acute or chronic problems.
• Conduct studies to understand capability for process and/or measurement systems.
• Provides management with technical guidance as required.
• Identify and develop appropriate documentation for process improvement and project implementation.
• Maintain liaison with individuals and units within or outside the organization with responsibility for acting independently on technical matters pertaining to their filed.
• You adhere to Integer’s Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.

Specific Supplier Quality responsibilities:

• You will manage supplier non-conformances, liaising with suppliers to ensure all issues are adequately addressed
• You will manage and conduct supplier audits, tracking the closure of any audit related findings.
• You will lead the suppliers’ product and process change notification system, as applicable
• You will lead Supplier Quality Agreement management process with suppliers.
• You will work with Suppliers, Management, Supply Chain, Engineers and Manufacturing associates in the resolution of supplier quality problems.
• Also, assist each of these groups with capability studies and the application of statistical quality control which include Cpk, DOE, Hypotheses Testing, etc.
• You will be responsible for managing the sourced item qualification process and ensuring all appropriate documentation is completed.
• You will be responsible for managing the First Article Inspection process.
• You will monitor supplier related KPIs, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained.
• You will review the adequacy and correctness of changes to Bill of Materials (BOM’s), Incoming Inspection Plans, Drawings, Component Specification, FMEAs, etc.
• You will be supplier quality resource for any site continuous improvement projects.
• You will support product transfers.
• You may provide supervision for up to 3 engineering direct reports.
• As well, you will serve as a coach and mentor for other engineers, modeling the behaviors and disciplines of an engineering or technical professional.

You are expected to collaborate with others in the exchange of information, ask questions and regularly check for understanding in support of your development as an engineer.

How you will be measured:

The specific measures listed below may be subject to change and are not intended to be an all-inclusive list.

Safety is our highest priority; you will be an active supporter of the Integer Environmental, Health & Safety programs.

Adhere to all Integer Values: Customer, Integrity, Candor, Inclusion, Collaboration, Innovation.

You will have defined Goals and Objectives specifying key projects and expected milestones to achieve.

Quality - Customer Direct Complaint Rate, NCR rate, Complaint Cycle Time, CAPA Cycle Time.

Innovation and ideation are critical aspects of your role and you will be expected to generate continuous improvement suggestions and support the implementation of them.

What sets you apart:

• Education and Experience: You are technically renowned as a subject matter expert, a recognition you have earned through 10+ years of progressive engineering and/or technically focused roles and experiences. You earned, as a minimum, a bachelor’s degree in an engineering or related technical field. Preferably, you also have a master’s degree or a Doctorate.
• Specialized Knowledge: You will have awareness of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA etc.) You will have good knowledge in Microsoft Office.
• Specialized Skills: You will demonstrate a solid technical aptitude with the ability to be an effective contributor to a team or produce results of a technical nature as an individual. You will demonstrate competencies in both written and oral communications. For outside of US countries, you will demonstrate competencies in both written and oral English communications. You will maintain a calm demeanor that transcends the high energy, constantly changing production environment. You will possess a positive, can‑do attitude with an underlying belief that failure is not an option.
• Salary Range: $143,500 - $210,540

Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success. Our compensation program includes base salary and a cash‑based incentive program supporting our pay-for-performance philosophy. We provide a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits. Parental leave is available after one year. Optional employee‑paid programs include supplemental life insurance, critical illness, hospital indemnity and accident insurance. Employees are immediately eligible to participate in the 401(k) plan with company matching contributions. We provide 80 hours (10 days) of company designated holidays per year plus an annual allotment of paid time off.

U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.

Integer Holdings Corporation (NYSE: ITGR) is one of the largest medical device contract development and manufacturing organizations (CDMO) in the world, serving the cardiac rhythm management, neuromodulation, and cardio and vascular markets. As a strategic partner of choice to medical device companies and OEMs, Integer is committed to enhancing the lives of patients worldwide by providing innovative, high‑quality products and solutions. The company’s brands include Greatbatch Medical® and Lake Region Medical®.

Additional information is available at www.integer.net. Integer Holdings Corporation (“Integer”) is an equal opportunity employer. We do not discriminate based on race, color, sex, religion, national origin, and on any other protected characteristics. We celebrate our many differences and remain committed to providing an inclusive workplace free from harassment and discrimination. Integer does not discriminate against any applicants or employees because he or she is a disabled veteran, Armed Forces service medal veteran, recently separated veteran, or active‑duty wartime veteran, campaign badge veteran, referred to collectively as "Protected Veterans." It is also the policy of Integer to employ and to advance in employment, all people regardless of their status as individuals with disabilities. All employment decisions are based only on valid job requirements. This policy shall apply to all employment actions, including but not limited to recruitment, hiring, promotion, transfer, demotion, layoff, recall, termination, rates of pay or other forms of compensation, and selection for training, including apprenticeship, at all levels of employment. Additionally, Integer provides reasonable accommodations to qualified job applicants and associates who need them for medical or religious reasons. This phone number and email address is strictly for the purpose of making a request for an accommodation. Status updates on your application cannot be provided to you through this phone extension or email. For status updates, please log in to https://integer.wd1.myworkdayjobs.com/en-US/External/login For remote eligible job postings, all work should be performed entirely outside of Alaska, California, Hawaii, Maine, Montana, and Washington. To review the Integer Applicant Global Privacy Statement, please click link below for your preferred language: English| Spanish| Malay| Chinese