Senior Manager Quality Engineering

Senior Manager Quality Engineering

Requirements

• BS/MS in engineering, science, or other relevant field.
• Minimum eight (8) years of experience in a regulated environment, with five (5) years of product design experience.
• Minimum of six (6) years supervision experience of engineers or other specialists.
• Strong Verbal, written communication, and presentation skills.
• Strong Technical writing skills.
• Ability to serve in leadership roles on projects or assignments.
• Comprehensive understanding of auditing principles and ability to perform as a lead auditor.
• Ability to participate and provide leadership on teams and maintain positive work environment with those teams.
• Ability to successfully lead time and handle multiple task assignments.
• Detail oriented and ability to organize large amounts of work and data.
• Plans efficiently and team oriented.
• Ability to travel up to 25%.

Responsibilities

• Represent the Corporation, Business Unit and Quality Department in a professional manner.
• Handle and ensure proper implementation of all Quality Engineering duties and responsibilities.
• Provide Quality Engineering leadership for New Product Development (NPD), Sustaining Engineering (SE) and transfer to manufacturing.
• Provide Quality Engineering technical support to assist in resolving quality issues, including but not limited to, complaint review and investigation.
• Prepare and implement Business Unit policies relating to quality, project management, product/process development, and design control regulations, etc.
• Participate on project teams as the Quality Representative.
• Create, review and approve Quality System Documents, including Product Documents for products purchased, manufactured and/or distributed by BD UCC.
• Create, review and approve Protocols, Process and Product Validations, Stability Protocols etc. to support the Design History File (DHF).
• Analyze process and product non-conformances and implement comprehensive corrective and preventive action plans (CAPA).
• Lead efforts to identify, investigate, and create plans to respond to potential product issues involving distributed product.
• Perform Supplier Quality Audits and participate as a lead or SME or equivalent experience in Corporate and/or Regulatory Body/Agency audits.
• Participate and have membership in trade and/or professional organizations to ensure that brand new industry standards are communicated into the division in an efficient, timely, and accurate manner.
• Provide technical support for complaint and adverse event review and investigation.
• Develop Quality indicators for new product launches and assure complaint metrics are supervised post launch.
• Work with manufacturing facilities, Durable Medical Equipment sites in the US (Liberator Medical and Tri-County Medical & Ostomy Supply), as well as in the UK and EU, and other Business Unit Facilities as required.
• Serve as an Independent QA Reviewer for Design Reviews, Design History File Audits (DHFa) and data integrity audits.
• Lead Quality Engineers on the team to complete their duties.

Preferred Qualifications

• Capital system (electro-mechanical) experience preferred.
• ASQ Certification(s) preferred.