Senior Quality Engineer

Location: Minneapolis, MN

Time Type: Full time

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

1. Adheres to GB Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.

2. Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.

3. Ability to interpret drawings, product/performance specifications, and other systems integration technical data. To participate in Technical reviews for Process development.

4. Monitors manufacturing of assigned products, assuring compliance with DMR and quality system requirements and assuring complete and correct Device History Records are maintained.

5. Leads product and process improvement initiatives and Implements various product and process improvement methodologies

7. Reviews the adequacy and correctness of changes to Bill of Materials (BOM’s), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.

8. Leads in the development, completion, and maintenance of risk analyses and Control plans

9. Leads generation and completion of protocols and reports for product, process, and test method validations.

10. Interfaces with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable.

11. Develops 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.

12. Ensures that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.

13. Leads and manage complaint investigations and remediation recommendations as needed.

14. Leads plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.

16. Works with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems through capability studies and the application of statistical quality control which include Cpk, DOE, Hypotheses Testing, etc.

17. Provides technical support to and work direction other Quality Engineers as needed.

18. Performs other functions as required.

19. Opportunity to lead Quality Technical also available for interest in people management Career Path.

Required:

- Strong Statistical techniques, Use of RCA approaches to deliver sustained improvements, Excellent Workload management to complete projects in a timely manner and Good Soft skills to interact and work with Key stakeholders to provide collaborative solutions.

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.