Quality Engineer I

Regulatory Jobs; Hudson (MA); On-site; USD 64,000 - 93,000; Full time

Benefits offered by this job

Medical, dental, vision

Disability and life insurance

401(k) with company match

Parental leave after one year

Holidays and paid time off

Job summary

Integer is seeking an entry-level engineer to support quality activities at our high-volume manufacturing site. You will apply general engineering methods under guidance from senior engineers to meet internal and external customer expectations while upholding our Quality Management System and regulatory requirements.

In this role you will assist with MRB, CAPA, change control, supplier quality, and product transfers; contribute to audits, non-conforming material handling, and continuous

Responsibilities

• Adhere to Quality Management System (QMS), safety, environmental and regulatory requirements (FDA, etc.).
• Support regulatory inspections, audits, investigations, and inquiries on product design and manufacturing quality.
• Monitor changes to BOMs, assembly procedures, drawings and specifications for accuracy.
• Participate in CAPA analyses and drive continuous improvement projects.
• Develop protocols and reports for test method validations and process capabilities.
• Lead disposition of non-conforming materials and supervise complaint investigations.
• Support internal quality audit activities and contribute to corrective/preventive actions.
• Promote standardization through 5S, standard work and training/certification.
• Engage associates, encourage problem-solving, and ensure effective communication.
• Align site quality activities with QA/RA metrics and strategic quality plans.

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.

Whatyou'lldo in this role:

The primary purpose of this position is to perform work which involvesgeneralengineeringmethods and tools.As an entry level engineer, you will ensurethatInteger’s internal and external customer expectations are met or exceededwith the direction, instruction and guidance from more experienced engineers and managers in your organization.

• You adhereto 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 withDMRwhile 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.

CreateTestMethods:

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-ConformingMaterialProcess:

You will ensure that the disposition of non-conforming materialsmeetall necessaryproceduresand assure adequacy of corrective actions to prevent re-occurrence.

You will lead and manage complaint investigations.

You will participate in plantCAPAactivities, 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 andobserve products and processesto 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."Youare astandardbearer for Quality in everything we do at Integer, by assuring adherence to our Quality Management System (QMS),supportingto corrective and preventive actionsinvestigation and implementation, and contributingtothe successful attainment of our quality KPI’s andjourney to differentiated quality.

Youmayperformother duties as needed and as directedby 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 thejourney 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 &visualcontrols (5S), Manufacturing Standard Work, and robust training &certificationprograms 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 ofbuilt-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.