Quality Engineer I-1

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 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.

The primary purpose of this position is to perform work which involves general engineering methods and tools.  As an entry level engineer, you will ensure that Integer’s internal and external customer expectations are met or exceeded with the direction, instruction and guidance from more experienced engineers and managers in your organization. 

• →You 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.

• 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.
• Adhere to all Integer Values: Customer, Integrity, Candor, Inclusion, Collaboration, Innovation
• You will have defined Goals and Objectives specifying key projects and expected milestones to achieve.
• Quality - Customer Direct Complaint Rate, NCR rate, Complaint Cycle Time, CAPA Cycle Time
• 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.

• Minimum Education:
  • You have earned, as a bachelor’s degree, minimum, 3-year degree in an engineering or related technical/ Science field. Candidates who do not meet the education requirement may be considered with 5+ years of relevant experience. Combination of relevant experience and technical degree could be allowed.

• Minimum Experience:
  •  0-3 years of experience.
• Specialized Knowledge:
  • You will have awareness of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA etc.)
  • You will have good knowledge in Microsoft Office
  • While you will have regular 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.
  • Knowledge of Good documentation practices development and review of quality documentation including procedures, work instructions, validation protocols, reports, and forms.
  • Equipment, process, utility, and computer system validation, including protocol development, execution, and report generation (IQ/OQ/PQ, Process Characterization, Process Validation, CSV, etc.). - (nice to have)
• Specialized Skills:
  • You will 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 will demonstrate competencies in both written and oral communications.
  • For outside of US countries, you will demonstrate competencies in both written and oral English communications
  • You will maintain a calm demeanor that transcends the high energy, constantly changing production environment.
  • You will possess a positive, can-do attitude with an underlying belief that failure is not an option.

• Desriable Skills:

• • FDA 21 CFR Part 820 and Part 11
  • ISO 13485 and ISO 14971
  • Validation lifecycle methodology
  • Areas and equipment qualification
  • Statistical analysis and problem-solving tools
  • Microsoft Office Suite and data analysis tools
  • Deep understanding of GMP and quality system requirements
    

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