Supervisor, Mfg/Ops Quality - US - Bay Area - Hayward

  • Illumina
  • US - Bay Area - Hayward
  • Oct 19, 2020
Full time Biotech

Job Description

Scope of the Position:

 

The Supervisor of the Return Material Authorization (RMA) Quality Engineering team oversees the RMA process. In this role, this individual addresses RMA quality issues to achieve business objectives and serves as a resource for problem solving throughout the field return investigation process. The Supervisor is expected to lead the RMA team in identifying, documenting, assessing, correcting and preventing quality issues.  The Supervisor will manage two Quality Engineers in a dynamic and fast-paced team environment, and work extensively with cross-functional peers.

 

Responsibilities:

  • Manage and develop the RMA Quality Engineering team, set team goals and priorities, and allocate resources to achieve team objectives
  • Provide support to RMA investigations
  • Support Engineering teams for RMA related activities
  • Ensure effective communication and collaboration with Engineering, Manufacturing and Supply Chain to support timely RMA processing and resolution of process issues
  • Perform RMA related data analysis, trending and reporting; identify the need for further investigation and/or Corrective and Preventive Action
  • Drive effective Corrective/Preventive Actions where appropriate based on analysis of field data trends/complaints
  • Partner with RMA leads at other Illumina sites to ensure process efficiency and compliance
  • Represent Hayward RMA for global Quality projects; determine local support needs for global projects  
  • Lead the activities for field related quality issues and escalations
  • Review and approve changes to RMA procedures and processes; ensure procedures are maintained and updated as needed
  • Assist Manufacturing Quality Engineering as required
  • Provide support for internal and external audits; represent RMA team in external audits
  • Other duties as required

 

Listed tasks and responsibilities are deemed essential functions for this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

 

Requirements:

  • Typically 1-3 years of supervisor/management experience preferred
  • At least 5+ years of quality experience in the biotechnology/medical device industry or a related FDA-regulated industry
  • Proficiency with Microsoft Office applications; experience with SAP
  • Demonstrated problem solving and critical thinking ability
  • Well-developed written and oral  communication skills; demonstrated ability to influence and lead
  • Strong working knowledge of FDA QSR Regulations and Guidelines, Medical Device Directives (MOD), harmonized standards, ISO 13485, MDSAP, and related quality standards, and the ability to apply them to daily operations
  • Adaptable to fast-paced, dynamic work environment with shifting demands

 

Education:

  • Bachelor's degree in a science, engineering, or technical discipline.

 

 

At Illumina, we strive to foster a diverse and inclusive workplace by cultivating an environment in which everyone contributes to our mission. Built on a strong foundation, Illumina has always been rooted in openness, collaboration, and seeking alternative views and perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and demonstrate our collective commitment to diversity and inclusion in the communities we live and work. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf