Quality Engineer III

Greatbatch Medical; Florida; On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical insurance

Dental and vision insurance

Disability insurance

Life insurance

Adoption benefits

401(k) with company matching

Parental leave after one year

Holidays and PTO

Job summary

Integer is a global organization delivering high-quality technologies and manufacturing for Medical Device OEMs and niche batteries across energy, military, and environmental markets. This role focuses on ensuring product quality, leading process improvements, and coordinating with regulatory and manufacturing teams in a fast-paced environment.

Ideal candidates have a bachelors degree in engineering, 5+ years in engineering roles, and familiarity with ISO/QSR standards, Six Sigma, and

Qualifications

• Bachelors degree in engineering or related field.
• 5+ years of progressive engineering and/or technically focused roles.
• Understanding of ISO, QSR, UL, MDD and related regs.
• Six Sigma experience (Green belt minimum, Black belt preferred).

Responsibilities

• Identify and evaluate procedures to ensure the production of quality product.
• Lead continuous improvement projects and CAPA activities.
• Develop test methods and document validations.
• Support inspections, audits, and deviation/waiver guidance.
• Collaborate with cross-functional teams to drive quality across manufacturing.

Education

Bachelors degree in engineering or related field

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 and a provider of high-end niche batteries for specialized applications in the energy, military, and environmental markets. 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:

• Ensure Integer internal and external customer expectations are met or exceeded.
• You Identify and evaluate 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.

Manufacturing Support:

• You will support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
• You will monitor manufacturing of assigned products, 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), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
• You will lead continuous improvement projects.
• You will assist with product transfers.
• You will perform work on technical projects where you will follow Integer’s standard quality management and production system methodologies to investigate opportunities for product and process improvements.
• 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.

Create Test Methods:

• You will lead the generation and completion of protocols and reports for test method validations.
• You will interface with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies.
• Recommends process monitoring devices where applicable.
• You will develop various inspection techniques and procedures to ensure product integrity to design specifications.
• Responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures.

Support Non-Conforming Material Process:

• You will ensure that the disposition of non-conforming materials meet all necessary procedures and assure adequacy of corrective actions to prevent re-occurrence.
• You will lead and manage complaint investigations.
• You will participate in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
• You will apply standard data analysis practices and observe products and processes to establish root cause for product and process failures or to support the justification for improvements to products and processes.

Support Site Quality Activities:

You will support internal quality audit activities, as applicable. You embed Quality– “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), supporting to corrective and preventive actions investigation and implementation, and contributing to the successful attainment of our quality KPI’s and journey to 5 Sigma. You may perform other duties as needed and as directed by your line of supervision. Support 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

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.

Minimum Experience:

Candidates who do not meet the education requirement may be considered with 10+ years of relevant experience.

Specialized Knowledge:

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), You will have awareness of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA etc.) You 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-dо 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. For remote eligible job postings, all work should be performed entirely outside of Alaska, California, Hawaii, Maine, Montana, and Washington.

Thanks for your interest in working on our team!!