Quality Engineer I

Integer Holdings Corporation; Hudson (MA); On-site; USD 64,000 - 93,000; Full time

Benefits offered by this job

Comprehensive benefits package

401(k) with company match

Parental leave

Paid time off (holidays)

Adoption benefits

Job summary

Integer Holdings Corporation is hiring an entry-level engineer focused on manufacturing quality and process improvement. The role emphasizes adherence to QMS, FDA regulations, and safety requirements, with guidance from senior engineers and managers.

You will support manufacturing quality, test method creation, non-conforming materials, and CAPA activities across site operations. The position offers base salary with a cash-based incentive, comprehensive benefits, and opportunities for continuous

Responsibilities

• Support regulatory inspections, audits, investigations, and inquiries regarding control and assessment of product design and manufacturing quality.
• Monitor manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and ensuring Device History Records are maintained.
• Review adequacy and correctness of changes to BOMs, Assembly Procedures, Drawings, Component Specifications, FMEAs, and Control Plans.
• Participate in continuous improvement projects and assist with product transfers.
• Develop and implement test methods, review processes for new/existing products, and coordinate validations and capability studies.
• Create and implement inspection protocols and procedures for Incoming, In-Process, and Final inspection.
• Lead root-cause analysis for non-conforming materials and participate in CAPA activities.
• Support internal quality audit activities and uphold the Quality Management System.
• Align strategies with site quality plans and sustain change management initiatives.

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 Support all Quality activities of a high‑volume hydrophobic coating plant, including: MRB support CAPA management Complaint investigation Audit support Change management NPI activities Continuous improvement

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 perform work which involves general engineering methods and tools. As an entry level engineer, you will ensure that Integer’s internal and external customer expectations are met or exceeded with the direction, instruction and guidance from more experienced engineers and managers in your organization. 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:

• Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
• Monitor manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained.
• Review adequacy and correctness of changes to Bill of Materials (BOM’s), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
• Participate in continuous improvement projects.
• Assist with product transfers.
• 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.

Create Test Methods:

• Support generation and completion of protocols and reports for test method validations.
• Interface with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies.
• Recommend process monitoring devices where applicable.
• 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:

• Ensure that the disposition of non‑conforming materials meet all necessary procedures and assure adequacy of corrective actions to prevent re‑occurrence.
• Lead and manage complaint investigations.
• Participate in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
• 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:

• Support internal quality audit activities, as applicable.
• Embed Quality– “I own Quality.”
• Act as a standard bearer for Quality in everything we do at Integer, by assuring adherence to our Quality Management System (QMS), supporting corrective and preventive actions investigation and implementation, and contributing to the successful attainment of our quality KPI’s and journey to differentiated quality.
• 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.
• Support the journey to differentiated quality.
• 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.

Salary Range

$64,350 - $93,170

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. If you are interested in applying for an employment opportunity with Integer and believe you will need an accommodation for the application or job interview processes, please contact us at [phone] or via [e-mail] so that we may discuss appropriate adjustments to our processes to enable you to be considered for a job opening. 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