Quality Systems Engineer

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?

What you’ll do in this role:

- You will 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.
- You will monitor compliance with company policies and procedures and support Quality Audits (Internal and External) activities, including auditing and providing support to address nonconformities.
- You will be responsible for Quality metrics preparation and reporting, including metrics for Supplier performance.
- You will drive continuous QMS improvement by developing procedures and gaining alignment across multiple functional departments.
- You will participate in developing and executing mitigation strategies to reduce risk associated with critical and high-risk suppliers.
- You will play an active role in Supplier management program by identifying the quality system needs for qualifying and monitoring suppliers.
- You will investigate and interpret internal or external Quality and Regulatory requirements and recommend best practices to the organization.
- You will provide QMS support throughout the organization and assisting with management and execution of CAPAs, NCs, complaint investigations, SCARs, etc.
- You perform other duties, as needed, and as directed by your line of supervision.

How you will be measured:

- Safety is our highest priority; you will be an active supporter of the Integer Environmental, Health & Safety programs.
- You will have defined Goals and Objectives specifying key projects and expected milestones to achieve.
- Given your capabilities and experience, you will be expected to identify ways to lead systemic changes to current processes and procedures that enable greater efficiencies.
- Innovation and creativity are critical aspects of your role, and you will be expected to generate continuous improvement suggestions and support their implementation.
- You will support a culture of quality and continuous improvement throughout the organization to ensure achievement of Global Quality KPI’s and goals.
- Your expertise coupled with your accomplishments and collaboration with others to deliver results will also be considered.

What sets you apart:

- You have earned, as a minimum, a bachelor’s degree in Science/Engineering discipline or related technical field or have 5+ years experience in a similar role.
- You have working knowledge of regional and international quality system requirements including 21 CFR 820, CFR Part 11, ISO 13485, EU MDR, MDSAP, and cGxP for Medical Devices
- Must have a strong understanding of quality system requirements and how each quality system element connects to another.
- You have strong medical device Quality System and Supplier Quality management background. Lead auditor qualification is an advantage.
- You have a strong technical and problem-solving foundation, and preferably training in a variety of problem-solving methodologies such as 8D, RCA, 5-Why, Ishikawa (Fish Bone).
- You work independently as well as collaboratively with cross functional teams.
- Clear and professional communications to all levels of the organization are important in this role and you will have well-developed written and oral communication skills.
- You possess a positive, can-do attitude with an underlying belief that failure is not an option.

U.S. Applicants: EOE/AA Disability/Veteran