MGR II QUALITY CONTROL

TE Connectivity plc

Middletown, DE

JOB DETAILS
SKILLS
Administrative Management, American Society for Quality (ASQ), Analysis Skills, Certified Quality Engineer (CQE), Coaching, Code of Federal Regulations, Communication Skills, Computer Skills, Corrective Action, Cross-Functional, Diversity, Documentation, Equipment Selection, Equipment Validation, FDA (Food and Drug Administration), Failure Analysis, ISO (International Organization for Standardization), Interpersonal Skills, Leadership, Maintain Compliance, Manufacturing, Medical Equipment, Medical Organizations, Mentoring, Performance Management, Presentation/Verbal Skills, Problem Solving Skills, Procedure Development, Procedure Implementation, Process Control Engineering, Product Support, Production Control, Production Support, Project/Program Management, Quality Assurance, Quality Control, Quality Engineering, Quality Management, Quality System Requirements (QSR), Regulations, Regulatory Compliance, Regulatory Requirements, Requirements Management, Sampling Inspection, Six Sigma Black Belt, Six Sigma Green Belt, Statistics, Strategic Planning, Talent Management, Team Lead/Manager, Team Player, Test Equipment, Time Management, Willing to Travel, Writing Skills
LOCATION
Middletown, DE
POSTED
30+ days ago

Job Description

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Job Title: MGR II QUALITY CONTROL

Posting Start Date: 5/12/26

At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.

Job Description:

Job Overview

The Senior Quality Manager is responsible for the administration, supervision, and development of the San Rafael Quality Assurance and Quality Engineering functions The role involves actively building a high-performance culture and driving the growth and development of talent within the team.

The role's purpose is to ensure full compliance with regulatory requirements such as 21 CFR 820, ISO 13485, RDC ANVISA 16/2013, MHLW MO 169, TG(MD)R sch3, MDR, and other applicable regulations, including production and process controls.

The Senior Quality Manager will report to the Global Head of Quality Operations

Job Requirements

  • Ensure that Material Review Boards are in place to ensure products are appropriately dispositioned within a timely manner, while ensuring appropriate corrective and preventive actions are initiated and regulatory requirements are met.

  • Develop and implement systems to assure that development as well as production teams receive support in the following areas:

  • Quality planning, including inspection techniques and sampling methods

  • Statistical Analysis

  • Biological testing

  • Application of required regulatory standards

  • Develop and implement procedures and systems to assure product manufactured for human use meets design and functional specifications. These systems are to include as a minimum:

  • Delivery of raw materials and components

  • Manufactured devices and equipment

  • Documentation associated with these functions

  • Leads performance management, develops talent and coaches the team.

  • Support regulatory agency and customer quality audits.

  • Ensure the conformity of the components and devices are appropriately checked in accordance with the Quality Management System before release.

  • Responsible for failure appraisal and analysis (internal and external).

  • Authority to place products or processes on hold.

  • Design and develop forms and instructions for recording, evaluating, and reporting quality data.

  • Corrective and Preventive Action program

  • Based on operational/quality requirements, assist in test equipment selection and validation.

  • Utilize formal problem-solving techniques to resolve product and/or process related issues.

  • As required, lead cross-functional teams to support resolution of product and/or process related issues or objectives.

  • Work with suppliers of both raw materials and components, to improve product quality and/or resolve quality issues.

  • Be innovative, knowledgeable and intensely committed to ensure that every product and service we supply conforms to FDA and Quality System Regulations as well as FDA QSR (21 CFR 820), ISO 13485, RDC ANVISA 16/2013, MHLW MO 169, TG(MD) Sch3/ MDD, MDR Standards.

Develop and implement systems to assure that development as well as production teams receive support in the following areas:

  • Quality planning, including inspection techniques and sampling methods
  • Statistical Analysis
  • Biological testing
  • Application of required regulatory standards

What your background should look like

  • Degree with a scientific or engineering emphasis.
  • ASQ Certified Quality Engineer recommended. Six Sigma Green/Black belt recommended.
  • Minimum of ten (10) years experience in a related regulated environment.
  • Experience should include positions at senior levels within the medical device organizations.
  • Proven experience leading teams within a manufacturing environment

Key Requirements:

To perform this job successfully, an individual should demonstrate the following competencies: Analytical, Design, Problem Solving Project Management, Technical Skills, Interpersonal Skills, Oral and Written Communication Skills, Teamwork, Judgment Motivation and Planning/Organizing Professionalism, Adaptability, Dependability, Initiative, Excellent computer skills Highly Motivated with a sense of urgency and be Proficient in the use and application of advanced statistical methodologies.

  • Ability to implement robust performance management systems.
  • Strong coaching and mentoring abilities.
  • Building effective teams

Competencies

SET : Strategy, Execution, Talent (for managers)

Job Locations:

Posting City: San Jose

Job Country: Costa Rica

Travel Required: Less than 10%

Requisition ID: 150465

Workplace Type: Onsite

External Careers Page: Quality

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About the Company

T

TE Connectivity plc

TE Connectivity is an industry leader with an entrepreneurial spirit, fueled by innovation and collaboration. Our emphasis on forward thinking has attracted the brightest industry minds, allowing them to thrive and create breakthrough solutions that deliver a competitive advantage to our customers.

TE Connectivity is a global, $12.1 billion company that designs and manufactures over 500,000 products that connect and protect the flow of power and data inside the products that touch every aspect of our lives. Our nearly 90,000 employees partner with customers in virtually every industry—from consumer electronics, energy and healthcare, to automotive, aerospace and communication networks—enabling smarter, faster, better technologies to connect products to possibilities.

COMPANY SIZE
10,000 employees or more
INDUSTRY
Electronics, Components, and Semiconductor Mfg
FOUNDED
2007
WEBSITE
http://www.te.com/usa-en/home.html