Quality Engineer II

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

Integer is a global medical device contract development and manufacturing organization providing innovative, high-quality technologies and manufacturing to Medical Device OEMs (original equipment manufacturers) to enhance the lives of patients worldwide. We are guided by our six core values, which include Customer, Innovation, Collaboration, Candor and Integrity. Working at Integer means you are a 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 job is to provide Quality Engineering support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance. Provide work direction for 1-3 Technicians/Inspectors.

• Adheres to Integer 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.
• 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 the adequacy and correctness of changes to Bill of Materials (BOM's), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
• Lead generation and completion of protocols and reports for test method validations.
• 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.
• 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.
• Ensure that the disposition of non-conforming materials meet all necessary regulatory requirements 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.
• Participate in continuous improvement projects.
• Assist with product transfers.
• Works with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems. Also, assists each of these groups with capability studies and the application of statistical quality control which include Cpk, DOE, Hypotheses Testing, etc.
• Mentor and support quality inspectors and technicians.
• Performs other functions as required.

Provide support of Integer's Manufacturing Excellence and Market Focused Innovation Strategies

• You champion the development of and deployment of the systems and tools to drive innovation and continuous improvement.
• You embrace the Manufacturing Excellence culture based on the Integer Production System and its five focus areas:
  • Strategy Alignment through Site Hoshin Plans, the regular cadence of Sales, Inventory, and Operations' Planning (SiOP) meetings, and regular updates to the value stream maps.
  • Leadership of Sustained Change by ensuring production monitoring & improvement activities and deployment of Leader Standard Work.
  • Standardization through workplace organization & visual controls (5S), Manufacturing Standard Work, and robust training & certification programs.
  • 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, optimized scheduling & material system designs, work cell design, and total productive maintenance.

How you will be measured:

• The specific measures listed below may be subject to change and are not intended to be an all-inclusive list

• Safety is our highest priority; you will be an active supporter of the Integer Environmental Health & Safety programs.
• Quality - Achievement of site Quality KPI's
• You will have defined Goals and Objectives specifying key projects and expected milestones to achieve.
• Given your capabilities and experience, you will identify ways to shorten the project durations and make changes to current processes and procedures that enable greater efficiencies.
• Innovation and ideation are critical aspects of your role and you will be expected to generate continuous improvement suggestions and support the implementation of them.

What sets you apart:

• You earned, as a minimum, a bachelor's degree in an engineering or related technical field; and have at least three years of relevant experience.
• Candidates who do not meet the education requirement may be considered with 7+ years of relevant experience.
• While you will have occasional support and guidance from more experienced engineers, supervisors or managers, you will demonstrate the ability to work independently as well as collaboratively with other associates and cross functional teams.
• You demonstrate a solid technical aptitude with the ability to be an effective contributor to a team or produce results of a technical nature as an individual.
• You have a functional understanding of the Integer Quality Management Systems and are able to complete required Quality System documentation tasks with little or no direction from others.
• You demonstrate competency in both written and oral communications.
• You maintain a calm demeanor that transcends the high energy, constantly changing production environment.
• You possess a positive, can-do attitude with an underlying belief that failure is not an option.

Quality Engineer II Salary: $70,500- $103,400

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