Senior Supplier Quality Engineer

Posted 15 Days Ago
Be an Early Applicant
Hiring Remotely in United States
Remote
Senior level
Healthtech • Manufacturing
The Role
In this role, you will oversee supplier quality activities, ensuring compliance with procurement standards and regulations. Responsibilities include validating processes, investigating quality issues, developing engineering projects, and leading cross-functional teams to enhance product performance and drive technological advancements.
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:

  • Reports on supplier quality related activities such as raw materials, contracted designed and manufactured items, packaging materials, good manufacturing process service providers to assure procurements meet or exceed the requirements.
  • Verifies and validates processes, monitors control activities and quality systems.
  • May perform deviation investigations into quality issues.
  • Prepares, maintains and reviews procurement quality assurance procedures to ensure compliance with customer and/or government requirements
  • Conducts research or development projects associated with the design and the development of new products or models.
  • Investigates and resolves technical problems involving product performance.
  • Coordinates development and design problems with research engineering, tooling, and manufacturing.
  • Follows up on the building of design and life test models, analyzing the test results.
  • Follows through on laboratory and field tests and develops new ideas based on results.
  • 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.
  • You will develop new and unique approaches to complex problems and lead projects to advance Integer’s technological capabilities.
  • You will investigate and interpret internal or external technology and business trends and recommend best practices to the organization.
  • You will evaluate, develop and implement a wide range of new technologies of significant scope and complexity.
  • You may identify and procure the new equipment and technology of significant complexity, scope and cost.
  • You will originate new documents such as protocols, reports, specifications and work-instructions; and you may also review documentation work product of peers and subordinates.
  • You will plan and develop engineering projects concerned with unique or high-profile problems which have an important impact on major programs.
  • You may lead cross-functional teams or projects with moderate resource requirements, risk and or complexity and may influence others to achieve goals.
  • You may provide supervision for up to 4 to 5 technicians and/or associate engineers. As well, you will serve as a coach and mentor for other engineers, where you will be modeling the behaviors and disciplines of an engineering or technical professional.
  • You will initiate and maintain relationships with individuals and business units within or outside your site or organization. And, as a subject matter expert in an engineering or specialty field, you may be directed to deploy your expertise across multiple organizations and/or locations. As a result, occasional travel may be required in this position.
  • You embed Quality within the Engineering discipline – “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 5 Sigma.
  • You perform other duties, as needed and as directed by your line of supervision.

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 be expected to identify ways to shorten project durations and lead systemic 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.
  • 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 an engineering or related technical field. Preferably, you may also have a Master’s Degree
  • You are technically seen as a subject matter expert, a recognition you have earned through 7+ years of progressive engineering and/or technically focused roles and experiences.
  • Candidates who do not meet the education requirement may be considered with 15+ years of relevant experience.
  • You have a strong technical and problem-solving foundation, and preferably training and certifications, in a variety of problem-solving and project management methodologies such as 6-Sigma (green belt as a minimum, black belt preferred), 8D, RCA, 5-Why, Ishikawa (Fish Bone), Kepner-Tregoe, PMP. 
  • Your abilities to observe, analyze and develop solutions to complex technical challenges result in the delivery of break-through results in areas such as productivity, technical capabilities, capacities, or other competitive differentiators.
  • You work independently as well as collaboratively with cross functional teams.
  • You will demonstrate the ability to lead team activities and act as a coach for other less experienced associates.
  • 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 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.

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

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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