Quality Systems Engineer II

Job Posted 7 Days Ago Posted 7 Days Ago
Hiring Remotely in United States
Remote
Junior
Healthtech • Manufacturing
The Role
This role leads quality assurance activities, develops quality systems, analyzes quality trends, and collaborates on process improvements while ensuring compliance with regulatory standards.
Summary Generated by Built In

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?  

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. 

What you’ll do in this role: 

Leads the execution and improvement of quality assurance and quality systems activities. Develops and manages quality systems that comply with national and global regulatory requirements. May lead and conduct detailed quality analyses including cost of quality trends and root cause analyses.

Accountabilities & Responsibilities:

  • Leads the execution and improvement of quality assurance and quality systems activities.
  • Develops and manages quality systems that comply with national and global regulatory requirements.
  • Develops new and unique approaches to complex problems and advance technology beyond previous company involvement.
  • May lead and conduct detailed quality analyses including cost of quality trends and root cause analyses.
  • Under the occasional supervision of experienced quality engineering mentors and managers, you will select and apply standard quality engineering techniques, procedures, and criteria in making adaptations and modifications to existing products and processes.
  • Leads the development and implementation of continuous improvement projects related to the electronic quality management system and quality system Power BI tools.
  • You will perform work on technical projects where you will follow Integer’s standard quality management methodologies to investigate opportunities for quality process improvements.
  • You will apply standard data analysis practices and techniques to establish root cause for quality system issues.
  • 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.
  • Plans/develops engineering projects concerned with unique or high-profile problems which have important effect on major organization programs.
  • You embed Quality within your daily work life – “I own Quality.”  You are a standard bearer for Quality in 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 to differentiated quality.
  • Assists with quality assurance functions in support of needs directed by Quality Management.
  • Performs other duties as required.

What sets you apart:

  • Minimum Education: At a minimum you have earned a bachelor’s degree in an engineering or related field and 3 years relevant experience.
  • Candidates who do not meet the education requirement may be considered with 5+ years of relevant experience.
  • While you will have occasional support and guidance from more experienced quality engineers and managers, you will demonstrate the ability to work independently as well as collaboratively with other associates and cross functional teams.
  • You possess experience with development and configuration of electronic quality management system software and Power BI tools.
  • 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 demonstrate a competency in both written and oral communications.
  • You maintain a calm demeanor that transcends the high energy, constantly changing work environment.
  • You possess a positive, can-do attitude with an underlying belief that failure is not an option.

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

Top Skills

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The Company
HQ: Plano, TX
2,909 Employees
On-site Workplace
Year Founded: 1940

What We Do

Integer Holdings Corporation (NYSE:ITGR) is a leader in advanced medical device outsourcing (MDO) and serves its customers by providing comprehensive end-to-end solutions with its unparalleled expertise in innovation and manufacturing. Integer's vision is to enhance the lives of patients worldwide by being its customer's partner of choice for innovative medical technologies and services. Additionally, through Electrochem, an Integer company, it develops custom batteries for high-end niche applications in energy, military, and environment markets. The company's medical device manufacturing brands include Greatbatch™ Medical and Lake Region Medical™. Additional information is available at www.integer.net.

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