Supplier Quality Engineer

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Santo Domingo
Healthtech • Manufacturing
The Role

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

Accountabilities & Responsibilities:

1. Adheres to Integer’s Core Beliefs and all safety and quality requirements.

2. Quality representative for Supplier Quality activities, both troubleshooting/CAPA and continuous improvement initiatives.

3. Develop, maintain and improve the supplier management program while assuring alignment and supporting Integer’s Inc. Supply Chain Organization initiatives and policies.

4. Determine strategies for continuous improvement in supplier quality and supply chain metrics.

5. Manage supplier’s corrective actions system (SCAR), investigation, documentation and implementation of corrective action and the verification of their effectiveness.

6. Design and/or specify inspection methods, tools, and test equipment to ensure product quality and design integrity are appropriately maintained. Also implements appropriate inspection sampling plans using statistical methods.

7. Manages the suppliers’ product and process change notification (PCN) system, including coordinating biocompatibility assessments.

8. Review and approve changes to supplier related documents (procedures, drawing, etc.).

9. Perform component qualifications, risk assessments, and first article inspections (as required) prior to the supplier implementing and/or performing the change.

10. Participates in supplier’s design review, product validation, design verification, Risk Management plans/reports (dFMEA, pFMEA).

11. Performs risk analysis for existing and new raw materials / components.

12. Develop and conduct statistically designed experiments to determine sources of material / component variability so that product quality is maintained or improved.

13. Monitor and assure Electrochem’s supply chain activity and procedure set is compliant to applicable sections of FDA quality system regulation and ISO 13485 regulation.

14. Support Integer’s, Inc. Supplier Management activities
 

Education & Experience:

  • Minimum Education:         Bachelor’s degree in engineering or equivalent.

                                                Master’s degree preferred.

                                          Certified Quality Engineer (CQE) or Supplier Quality (CSQP) preferred.

  • Minimum Experience:        5 - 8 years of experience in Quality, Supplier Quality, Supply Chain or related                                                process driven field.

                                          Or an equivalent combination of education, training or experience.

  • Knowledge & Skills:
  • Special Skills:
  • Excellent communication (written and verbal) skills with internal and external customers.
  • Presentation skills.
  • Ability to work in a matrix organization, strong analytical skills.
  • Problem solving and skills.
  • Proven leadership, communication, and project management..
  • Specialized Knowledge:
  • Problem solving skills: Develop technical solutions to complex problems, which require the regular use of creativity.
  • Negotiating, influence and leadership abilities.
  • Computer knowledge: MS Excel, MS Word, MS Power Point, Minitab.
  • Quality System Audits knowledge.
  • Drawings and blueprints knowledge.
  • Measurement and test equipment knowledge.
  • Other:  
  • Quality Driven
  • Teamwork Centered
  • Self-Driven
  • Relentless Communicator
  • Customer Champion
  • Effective Problem Solver
  • Out of the Box Thinker
  • Detail Oriented

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

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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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