Quality Engineer I

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

Benefits offered by this job

Medical, dental, vision

disability insurance

Life insurance

Adoption benefits

401(k) with company match

Paid holidays

Paid time off

Job summary

Integer Holdings Corporation is seeking an entry-level engineer to support quality and manufacturing operations. You will work under guidance to ensure compliance with QMS, FDA regulations, and safety requirements while assisting in CAPA, MRB, and audit activities.

You will monitor manufacturing processes, review changes to BOMs and procedures, and participate in continuous improvement projects as part of a high-volume production environment.

Qualifications

• Entry-level engineer with guidance from more experienced engineers and managers.
• Must adhere to FDA regulations, QMS and safety requirements.
• Experience with CAPA, MRB, audits, and change management is a plus.

Responsibilities

• Support regulatory inspections, audits, investigations, and inquiries related to device design and manufacturing quality.
• Monitor manufacturing for compliance and maintain Device History Records.
• Review changes to BOM, assembly procedures, drawings, and FMEAs.
• Participate in continuous improvement projects and product transfers.
• Collaborate with others to exchange information and ensure understanding in development.

Skills

Quality management

Regulatory compliance

Cross-functional collaboration

Root cause analysis

Process improvement

Education

Bachelor's degree in Engineering

Tools

QMS software

BOM review tools

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

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

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

• 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 participate in 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 support 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 differentiated quality.

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 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.

#IND1

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.