Associate Manager, Supplier Quality Engineering

AtriCure, Inc. has an opening for the Associate Manager, Supplier Quality Engineering in Mason, OH responsible for management of a supplier quality engineering group and processes that affect technical product quality and impact the state and control of finished product in compliance with global regulatory requirements (ISO, FDA, MDD, MDR, etc.).

Duties include:

• Manage assigned group’s Supplier Quality Engineering activities by providing quality leadership and direction to quality engineers on team to ensure objectives are met in a timely manner. Supplier Quality activities include:
  • New component qualification;
  • Expansion Activities (within existing supplier or with alternate supplier);
  • Supplier Requested Changes;
  • Processing of Component NCRs;
  • Manage communications with supplier regarding all quality activity;
  • Assess Supplier Performance and initiating SCAR activities when required; and
  • Assist in completion of Supplier Audits.
• Balance responsibilities and projects within team to best utilize resources;
• Work with Sr Manager, Quality Engineering to manage the tactical execution of short and long-term quality engineering and production and process control objectives;
• Partner with key suppliers to enhance their ability to consistently deliver the highest quality components and assemblies and drive for minimized inspection requirements and supplier related non-conformances through carefully planned strategic initiatives;
• Provide leadership, mentoring, and development plans for all direct reports to maintain an engaged and productive workforce;
• Utilize proven techniques and knowledge of functional area to significantly contribute at the individual contributor and manager level;
• Interact with direct reports and functional peer group managers;
• Participate and present at meetings with internal and external representatives, leading a cooperative effort among members of a project team;
• Provide input for hiring, mentoring, and counseling employees, including performance reviews and disciplinary action as needed;
• Compose and present reports to management summarizing activities;
• Support and/or perform external/internal audits as necessary; and
• Up to 10% international or domestic travel to AtriCure and customer sites.

Required:

• Bachelor’s degree in Engineering, Manufacturing Technology or a related field (foreign equiv. degrees accepted)
• 4 years of progressive, post degree experience as a Quality Engineer, Supplier Quality Engineer, Manufacturing Engineer, Process Engineer or related.

• 4 years of experience in:
  • Planning and implementing manufacturing process controls such as inspection, testing, and measurement processes;
  • Process Validation and Test Method Validation;
  • Operating within a FDA Regulated or ISO 13485 facility; and
  • Experience with quality tools and practices, such as Failure Modes Effect Analysis (FMEA), Root Cause Analysis (RCA), Process Capability, and Gaging Studies.
• 2 years of experience:
  • Working cross-functionally with R&D, Manufacturing Engineering, Supply Chain, Operations, Regulatory, and Marketing functions; and
  • With single use, sterile, packaged medical devices

• Also requires:
  • Demonstrated communication skills gained from regular presentations to senior level management while facilitating discussion in the last two years; and
  • Completion of multiple CAPAs or SCARs in the past two years resulting in measurable improvement

Experience may be gained concurrently. Ability to pass pre-employment drug screen and background check is required.

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