Senior Manager Product Quality Management

About the role

Through partnership with Supply Chain (Ops, Value stream), R&D, QA, and commercial leadership, this position leads the monitoring, analysis and improvement of all aspects of brand quality from NPI through to the customer as well as the communication back to commercial on the brand health, to improve brand equity. In parallel to the field performance, work with regulatory and quality systems both at an operating company level and an enterprise level, to look at the health authorities’ compliance landscape and incorporate proactively in the improvement strategy. As a result, the position leads the strategic 10-year overview quality plan per brand addressing patient needs, using a combination of new product and improvement approaches. The role is based in Milpitas, CA or Irvine, CA with a preferred location in Irvine, CA and requires up to 10% domestic and international travel.

Responsibilities

• Act on the strategy and hold key quality decisions on the brands.
• Partner with commercial organization, regional offices, Regulatory and Complaint handling to gather all short and long term information on the brands as they relate to performance in the field.
• For new products, partner with R&D leadership to modify the new product development to optimize product quality; assess these launches as they relate to product quality and have the scope to accelerate, modify or delay new product launches.
• For existing products, partner with Supply Chain Leadership to assess and implement modifications to the manufacturing processes and lead the strategy of manufacturing improvements as they relate to product quality.
• Rely on two dedicated Engineering groups (NPI Quality Engineering and Customer Experience Engineering, over 20 engineers) to conduct technology research and implement the strategy led by Product Quality Management in sync with R&D and Supply chain engineering; lead the over‑arching CAPAs on the topic.
• Be accountable for short‑term brand decisions: review and assess any brand‑wide deviation from design intent, co‑own product decisions with the site quality leader, and hold signature authority on non‑conformances and change control for assigned product lines; be accountable and signatory for quality plans, control plans, major changes and validations.
• Communicate to all levels of the organization and integrate the brand quality plan into the overall product value stream with specific and quantifiable business outcomes.
• Be measured by the brand scorecard health, which includes internal Quality metrics (NCs, Quality events), external Quality metrics (such as Customer complaints), Supply chain metrics (such as COGS) and Commercial metrics (such as adherence to BP).
• Adhere to environmental policy and procedures and support department environmental objectives.

Requirements

Education:

• University / Bachelor’s Degree or Equivalent (required)
• Bachelor’s Degree in Statistics/