Quality Engineering Manager

The Quality Engineering Manager develops and implements quality plans, metrics, projects, and processes necessary to ensure Brooks Automation products are of the highest quality and drives a Zero-Defect culture throughout the organization. Brooks’ product reliability, performance and quality must conform to established company, customer and regulatory requirements.

The Quality Engineering Manager will identify and coordinate cross-functional resources to eliminate quality discrepancies and implement long term Quality improvement plans.

Success in this role will require the ability to foster strong working relationships with functional leaders throughout the organization. The Quality Engineering Manager will work with Manufacturing, Engineering, Sales, Service, Program Management, Product Management, and Supplier representatives to ensure product quality requirements are met and constantly improve.

This specific role will be based in Brooks Life Sciences’ Rangeway, Chelmsford MA site and reports directing to the Senior Vice President of Quality in Brooks’ Manchester, UK site.  This Quality manager role will have ownership of quality for the Brooks Life Sciences Cryogenic product line.  As Quality manager, this role will be a member of the Cryogenic product leadership team and a member of the Rangeway Site leadership team to contribute to the way the site operates.

RESPONSIBILITIES AND KEY FOCUS AREAS:

• Leads and coordinates cross-functional teams to achieve quality goals and implement robust corrective and systemic preventive actions
• Cryogenic Quality engineer and Quality Control Technicians will report to this position
• Identifies and ensures quality requirements are met in new product introductions
• Leads quality meetings with site and corporate leadership
• Leads problem solving teams utilizing 8D methodology
• Manages failure analysis, report generation, customer reviews and local audits
• Provides Quality support to Brooks Manufacturing sites and Contract Manufacturers
• Conducts Data Analysis and prepares metrics detailing field product quality.
  • Collect, treat and interpret data, analyze results using statistical techniques
  • Identify, analyze and interpret trends or patterns in complex data sets
  • Works with staff as necessary to enhance data capture and analysis in support of internal and external quality improvement and reporting efforts as needed
  • Serves as a resource of aggregating, analyzing, and displaying statistical data
• Leads the specification of quality assurance tests; and performs statistical analysis to assess the cost of and determine responsibility for, products or materials that do not meet required standards and specifications.
• Assists in the process for ensuring that corrective actions (CAPA) are completed in accordance with relevant ISO requirements (ISO 13485) and that documentation is complete and compliant with requirements
• Support all company safety and quality programs and initiatives

  WHAT WE’RE LOOKING FOR:

• Must be able to demonstrate the application and appropriate use of statistical methods and tools (such as DOE, Hypothesis Testing, ANOVA, Gauge R&R, Statistical Process Control, Capability analyses, Weibull etc.).
• Ability to present options and suggestions leading to business level decision making founded in sound data driven analysis
• Ability to lead directly and indirectly across multiple sites and prioritize multiple tasks on an on-going basis
• Excellent organizational and communication skills, both verbal and written
• Proficient in using Oracle, Microsoft Word, Access, Excel, PowerPoint, Minitab and report writing software
• Desire to work in a fast-paced environment
• Willingness to travel up to 25% both Domestic and International

EDUCATION / EXPERIENCE

• B.S. or higher in a technical discipline is required with at least five years of professional work experience as a Quality Manager supporting technical products.
• Experience with Life Science products and contract manufacturing desired. Medical device regulatory experience, which would include experience of ISO 14971, would also be advantageous

EOE  M/F/Disabled/VET