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

What You Will Do In This Role

The primary purpose of this position is to support the Life Sciences group in one or more of the following areas: sterilization, environmental monitoring, product cleanliness, and biocompatibility. In this role, you will ensure that Integer's Life Science requirements are met or exceeded with occasional direction, instruction and guidance from more experienced associates and managers in your organization. You will continue to learn the application of microbiological and biocompatibility concepts in the manufacturing of a medical device.

• Adheres 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.
  
  

Support Life Sciences Activities

• You will generally work independently with occasional guidance from experienced Life Science mentors and managers to review and apply the applicable standards and procedures, to provide support in one or more of the following areas: sterilization, environmental monitoring, product cleanliness, and biocompatibility.
• You will write and review protocols, reports, and other documents related to sterilization, microbiological test methods, and/ or biocompatibility.
• You will perform work on technical projects, where you will follow Integer's standard quality management, production system and/ or laboratory methodologies, to evaluate, maintain and improve the quality of medical devices.
• You will apply standard data analysis practices and techniques, under guidance of experienced Life Sciences associates, to establish root cause for out of specification results, and to support the justification for improvements.
• You are expected to collaborate with others in the exchange of information, ask questions, and regularly confirm your understanding with Life Science mentors, in support of your development as a Life Science associate.
• You may perform other duties as needed and as directed by your line of supervision.
  
  

Support Quality and Manufacturing Excellent Imperatives

• You embed Quality within all that you do – "I own Quality." You are a standard bearer for Quality in
  
  

Reports To: Quality Manager or Senior Manager, Global Life Sciences

Location: Varies Career Band Level: P2

Job Group: Quality Exemption Status: Exempt

Job Group Family: Life Sciences Date Revised: May 2023

everything we do at Integer, by assuring adherence to our Quality Management System (QMS), facilitating and/or contributing to corrective and preventive actions, and contributing to the successful attainment of our quality KPI's and journey differentiated quality.

• Provide support of Integer's Manufacturing Excellence and Market Focused Innovation Strategies
• Participation or leadership through Site Hoshin Plans, Quality Plans, Validation master plans, associated quality improvement imperatives
• Provide leadership as required for QA RA weekly and monthly metrics, supporting the walk to 5 sigma.
• Leadership of Sustained Change ensuring customer change notifications are initiated and completed, as necessary, and supporting continuous improvement activities as required.
• Support the 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.
  
  

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.
• You will have defined Goals and Objectives specifying key projects and expected milestones to achieve.
• Quality – Achievement of site Quality KPIs
• 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 have earned, as a minimum, a bachelor's degree in Biology, Microbiology, or related technical field, and have at least 3 years of experience.
• If you do not meet the education requirements, you may be considered with 7+ years of relevant experience.
• While you will have occasional support and guidance from more experienced Life Science associates, you will demonstrate the ability to work independently as well as collaboratively with other associates and cross functional teams.
• You will demonstrate a solid technical aptitude with the ability to be an effective contributor to the team or produce results of a technical nature as an individual.
• You will demonstrate competencies in both written and oral communication.
• You maintain a calm demeanor that transcends the high energy, constantly changing product environment.
• You possess a positive, can-do attitude with an underlying belief that failure is not an option.
  
  

Working Conditions

• The working environment varies from a standard office environment to laboratory and production areas including cleanrooms with varying physical conditions, gowning requirements and high noise levels.
  
  

U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.
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