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Site Quality Manager IC - Wilsonville, Oregon


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 Overview

The Site Quality Manager is responsible for the administration, supervision, and development of the site Production, Supplier quality and Quality Engineering functions at the Site.  The Site Quality Manager will report directly to the Global Head of Quality Interconnect and report through the Interconnect Product business Unit (PBU). They will have dual responsibility for the site QMS that covers both Metals and Interconnect PBUs. This position is responsible for ensuring full compliance to applicable regulatory requirements such as 21 CFR 820, ISO13485, MDR and other regulations affecting the production and distribution of products and provision of related services and activities across the Site. The Site Quality Manager will be part of the Site/ Campus Leadership Team and will partner with colleagues within quality and other functions to ensure strong compliance, product quality, and efficient use of resources and systems.

Job Responsibilities

  • Develops a strong quality organization that supports the business and delivers global and local objectives. 
  • Responsible for Production, Supplier Quality, Quality engineering for the Site interconnect business  
  • Responsible for Campus QMS, Calibration and Quality TEOA activities, as well as quality standardization initiatives which currently includes the launch of E-QMS Smartsolve System and support of site SAP initiatives. 
  • Responsible for Site Quality Metric Reporting ensuring deadlines are met.
  • Ensure compliance for all activities at the Site, noting QMS covers both the Interconnect and Metals Business Units, as the Campus is on the same ISO Certification. Ensures Management rep is identified at appropriate level.
  • Ensures that the Site Internal Audit / Customer audit program is planned and effective.  Ensure process is in place to handle customer survey and quality agreement inputs. 
  • Leads and demonstrates expertise in the areas of QSR and applicable ISO standards, constantly promoting awareness of industry best practices and making appropriate decisions. 
  • Leads and/or supports audits from external regulatory agencies and Notified Bodies (US FDA, BSI/LRQA, etc.) and customers, and ensures preparation activities in advance of such audits.
  • Ensures customer issues are professionally addressed in a timely manner and escalates critical issues as appropriate. 
  • Work with Operations and Engineering teams to identify and drive actions that reduce the Cost of Poor Quality. 
  • Develops a strong working relationship with internal and external customers. 
  • Participates in new product introductions to ensure quality is built into all products early in their life cycle. 
  • Ensure effective and efficient process controls are implemented and maintained (inspection standards, plans, frequencies, and test methods). 
  • Drives continuous improvement initiatives to enhance the site quality system and product quality while ensuring compliance with governing regulations and corporate policies and procedures. 
  • Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product. 
  • Utilize best-in-class problem-solving tools to drive robust and effective corrective and preventive actions through the CAPA system. 
  • Active lead role in the execution of the site’s business & operational excellence (TEOA) Program. Ensure fast response is implemented to customer complaints and other KPi’s.
  • Provide guidance to the business and oversight on execution in areas such as transfer qualification strategy, qualification of facility expansions/Cleanroom modifications etc. 
  • Demonstrates Strong Leadership skills, including:
    • Building an effective, diverse team and helping to drive strong engagement 
    • Coaching staff to perform effectively in their work and ensures the training is documented and completed on time. 
    • Ensures team presents clear concise messages in presentation and emails for status reviews and escalations.
    • Creating a strong team working environment with a focus on customer needs, compliance, product quality, and risk mitigation. 
    • Promoting quality in the organization and motivates others towards their commitment to patient safety and product quality.
    • Developing talent by ensuring staff has strong development plans with regular feedback. 
       

What your background should look like:

  • Bachelor’s Degree with a scientific or engineering emphasis desired.
  • ASQ Certified Quality Engineer recommended. Six Sigma Green/Black belt recommended.
  • Minimum of 7 years' experience working in quality 
  • Quality leadership experience 
  • Strong knowledge of ISO13485/US FDA QSRs is ideal 
  • Knowledge of SAP and Smartsolve (e-QMS) is ideal
  • People management experience is essential

 

Key Requirements:
To perform this job successfully, an individual typically demonstrates the following competencies: 

  • Ability to manage and develop direct and indirect reports.
  • Prioritize multiple projects and activities.
  • Communicate effectively with multiple levels of the organization.
  • Utilize analytical approaches to problem solving and implementing improvements.
  • Collaborate with colleagues to share knowledge and experiences.
     

Competencies

Motivating Others
Managing and Measuring Work
Building Effective Teams
Values: Integrity, Accountability,Teamwork, Innovation
SET : Strategy, Execution, Talent (for managers)

About TE Connectivity

TE Connectivity is a global industrial technology leader creating a safer, sustainable, productive, and connected future. Our broad range of connectivity and sensor solutions, proven in the harshest environments, enable advancements in transportation, industrial applications, medical technology, energy, data communications, and the home. With more than 85,000 employees, including over 8,000 engineers, working alongside customers in approximately 140 countries, TE ensures that EVERY CONNECTION COUNTS. Learn more at www.te.com and on LinkedIn, Facebook, WeChat and Twitter.

What TE Connectivity offers:
We offer competitive total rewards compensation. Our commitment to our associates includes offering benefit programs that are comprehensive, competitive and will meet the needs of our associates.

  • Generous 401(k) Plan
  • Tuition Reimbursement
  • Benefits start on day one
  • Charity Donation Matching Program
  • Competitive Paid Time Off
  • Employee Resource Groups
  • Employee Stock Purchase Program
  • Healthcare for Associates and Families
  • Health and Wellness Incentives
  • Life Insurance and Disability Protection

Throughout our Global reach and various Business Units, we take a balanced approach to the benefits we provide. Many benefits are company-paid, while others are available through associate contribution. Specific benefit offerings can vary by location.

 

EOE, Including Disability/Vets

Location: 

WILSONVILLE, OR, US, 97070-9289

City:  WILSONVILLE
State:  OR
Country/Region:  US
Travel:  Less than 10%
Requisition ID:  93239
Alternative Locations: 
Function:  Engineering & Technology


Job Segment: Facilities, Six Sigma Black Belt, Quality Engineer, Compliance, Six Sigma, Operations, Management, Engineering, Legal

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