Quality Systems Engineer III

Integer Holdings Corporation; Chaska (MN); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Medical, dental, vision

Disability and life insurance

Adoption benefits

Parental leave

401(k) with company match

Paid time off and holidays

Job summary

Integer Holdings Corporation seeks a Quality Systems professional to support and improve QMS processes. The role emphasizes CAPA/NCR investigations, data-driven improvements, and cross-functional collaboration to meet quality KPIs.

You will lead and coach teams, maintain strong documentation, and support internal and external audits as part of a comprehensive quality program in a dynamic manufacturing environment.

Qualifications

• Bachelor’s degree in engineering or related field required.
• 5+ years of progressive engineering/technical roles.
• Green belt (minimum) in Six Sigma; black belt preferred.
• Ability to observe, analyze and solve complex issues.
• Lead teams and coach others; strong communication skills.

Responsibilities

• Support and improve the Quality Management System (QMS).
• Investigate CAPA, NCRs, and quality issues with timely resolutions.
• Prepare and review quality documentation and metrics (KPIs).
• Collaborate with cross-functional teams to drive improvements.
• Assist audits and regulatory inspections as needed.

Skills

Quality engineering

Root cause analysis

Cross-functional collaboration

Data analysis

Problem solving

Education

Bachelor's degree in engineering

Master's degree (optional)

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.

General Quality System Support and Collaboration

• You will select and apply standard quality engineering techniques, procedures, and criteria in making adaptations and modifications to existing products and processes.
• You will lead cross functional teams or projects with minimal resource requirements, risk or complexity and may begin developing the skills to influence others to achieve goals.
• You will develop new and unique approaches to challenging problems and work on projects that advance Integer’s quality systems.
• You will originate new documents such as procedures, work instructions and reports to meet quality system requirements. You may also review documentation from peers and others.
• You will perform work on technical projects where you will follow Integer’s standard quality management methodologies to investigate opportunities for quality process improvements.
• You will apply standard data analysis practices and techniques to establish root cause for quality system issues.
• 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.

Audit Support

• You are responsible to support internal and external audits. Provides support for external regulatory inspections and customer audits.
• Support the timely response and closure of audit observations and findings and reviews and maintains corrective actions from audit findings.
• You may be required to achieve a lead auditor status.

Management Review Support

• You are responsible for assisting in preparing, coordinating, and documenting the sites Quality Management Review.

Issue Resolution Support

• You provide tracking and support for customer notifications.
• You provide Quality Systems and Compliance consulting related to CAPA, Complaint Investigations, and other compliance topics.
• You provide support for CAPA and NCR investigations as needed to insure timely and accurate processing.
• You complete trending and evaluation of data for quality system metrics.

Additional

• You embed quality within your daily work life – "I own Quality." You are a standard bearer for quality in everything we do at Integer, by assuring adherence to our Quality Management System (QMS), facilitating and/or contributing to corrective and preventive actions, and contributing to the successful attainment of our quality KPI’s and journey to 5 Sigma.
• Assists with quality assurance functions in support of needs directed by Quality Management.
• Performs other duties as required.

Support of Integer’s Manufacturing Excellence and Market Focused Innovation Strategies

• Strategy Alignment through Site Hoshin Plans, Quality Plans, Validation master plans, associated quality improvement imperatives, and regular updates to QA RA weekly and monthly metrics, supporting the walk to 5 sigma.
• Leadership of Sustained Change ensuring customer change notifications are initiated and completed, as necessary, and supporting continuous improvement activities as required.
• Standardization through workplace organization & visual controls (5S), Manufacturing Standard Work, and robust training & certification programs where applicable.
• Associate Engagement promoted through the adoption of standardized problem solving methodologies, behavior-based safety programs, and improvement idea and suggestion systems.
• Systems & Process Optimization through adoption of principles of built in quality.

How you will be measured

• 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 – Achievement of site Quality KPI’s.
• Innovation and ideation are critical aspects of your role.

What sets you apart

• Minimum Education: At a minimum you have earned a bachelor’s degree in an engineering or related field and may have earned and master’s degree.
• You are technically seen as a very competent technical contributor, a recognition you have earned through 5+ years of progressive engineering and/or technically focused roles and experiences.
• Candidates who do not meet the education requirement may be considered with 10+ years of relevant experience.
• You have a strong technical and problem-solving foundation, and preferably training and certifications, in a variety of problem-solving and project management methodologies such as 6-Sigma (green belt as a minimum, black belt preferred).
• Your abilities to observe, analyze and develop solutions to challenging technical issues result in the delivery of measurable results in areas such as productivity, technical capabilities, capacities, or other competitive differentiators.
• You work independently as well as collaboratively with cross functional teams.
• You will demonstrate the ability to lead team activities and act as a coach for other less experienced associates.
• Clear and professional communications to all levels of the organization are important in this role and you will have well-developed written and oral communication skills.
• You maintain a calm demeanor that transcends the high energy, constantly changing work environment.
• You possess a positive, can-do attitude with an underlying belief that failure is not an option.

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. Integer provides reasonable accommodations to qualified job applicants and associates who need them for medical or religious reasons.

For remote eligible job postings, all work should be performed entirely outside of Alaska, California, Hawaii, Maine, Montana, and Washington.