Sr. Quality Engineer

1 month ago

Gurugram, India Hollister, Inc. Full time
Summary:

Supplier Quality Engineer is a professional position with focus on global management of supplier selection, evaluation, monitoring, and re-evaluation activities through direct supplier management and through supplier owner support.

Support the Global Supplier Quality in assuring quality products for Hollister's customers. This role includes operating as a core member (or leader) of project teams for new product development and change implementation. Evaluate and manage suppliers, aid by identifying quality improvement initiatives and cost savings. Address quality concerns for current products, development opportunities, and process improvements that positively impact the Hollister Quality Management System. Partner with the cross-functional team members to achieve Global Quality objectives compatible with Hollister Mission and Vision.

Responsibilities:
  • Drive Supplier selection and evaluation process of new and existing suppliers. Execute quality agreements and perform audits as part of initial assessment and ongoing management of Supplier relationships; ensure compliance with relevant quality system regulations.
  • Act as primary quality contact with suppliers, working with them to solve issues that arise and recommend improvements.
  • Monitor supplier quality performance metrics and drive resulting corrective/preventive actions determined to be necessary.
  • Actively help maintain and improve a Quality System compliant with FDA regulations and ISO 13485 (e.g., training documents, procedures, work instructions, specifications, labeling)
  • Assist in any external regulatory audits (FDA, notified body) in support of the Hollister Quality Management System
  • Interface with internal functions, such as Design Assurance, Global Engineering, and R&D, on new product development projects and significant changes related to supplier processes. Support development and maintenance of Design History File (DHF) and Technical Files for Hollister-owned design and private label products.
  • Utilize strong understanding of statistical analysis methods (ANOVA, Hypothesis testing, process capability analysis, DOE, GR&R, survival analysis, measurement system analysis, etc.) to ensure that manufacturing processes are appropriately qualified, and requirements are met prior to commercialization.
  • Contribute to or lead Risk Management activities for new or existing products, including but not limited to risk assessment, DFMEA, PFMEA
  • Identify and implement cost savings opportunities by partnering with Operations and Engineering
  • Mentor and train others on subject matters related to the certified quality engineering body of knowledge and manufacturing principles and practices


Essential Functions of the Role**:
  • Work in an office environment is required as well as in labs and manufacturing sites.

Work Experience Requirements
  • Number of Overall Years Necessary: 8-12


  • 8-12 years overall experience is required
  • Minimum of 5 years' experience in a Quality Engineering (or equivalent industry discipline) required
  • Experience supporting new product design and interacting with supply base to assure successful outcomes (Design Controls) is required
  • Experience in Medical Device Manufacturing in compliance with applicable foreign and domestic regulations including US FDA 21 CFR Part 820, ISO 13485, EU Medical Device Regulation.


Education Requirements
  • Click here to enter text.
  • Bachelor's degree is required; Engineering, Math, Physical Sciences, Computer Science or related study is preferred
  • Master's Degree preferred


Specialized Skills/Technical Knowledge:
  • ASQ Certified Quality Engineer highly desired
  • Knowledge and experience in statistical software packages (ex. Minitab) for data analysis
  • Project management
  • ASQ Certified Quality Auditor or Recognized Lead Auditor Certification Program
  • Basic technical writing skills required; advanced technical writing skills preferred
  • Knowledge of SAP/ERP Systems a plus
  • Ability to train / facilitate others inside and outside of the company
  • Good communication skills, both written and oral, to an international supply base with varied cultural expectations
  • Ability to travel domestically/internationally 20-30%


Location : Gurugram

Work Mode : Hybrid

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