Manager, Production Quality Engineering

Job Overview

Manages manufacturing plant quality engineering programs, processes, activities, and responsibilities supporting current operations and new product introductions. Manages quality assurance and quality control personnel in the execution of their quality related duties. Interacts with other manufacturing departments (production, maintenance, engineering etc.) as well as with support personnel, suppliers and other external parties on issues related to quality. This position will interface with employee at all levels and various functions / departments across the business and within a facility.

Job Responsibilities and Essential Duties

• Day to Day Production Support (80%)
  
  
  
  • Manage the nonconformance and crash cart processes
  • Organize support of all product related CAPAs
  • Support Ship Holds from an engineering perspective to identify scope and disposition materials
  • Support and own production related HHEs
  • Lead and execute root cause analysis to determine failure causes and implement failure reduction and elimination strategies.
  • Ensure plant policies and procedures are in compliance with all FDA regulations.
  • Improve and maintain a manufacturing Quality Management System and team that contributes to outstanding customer service and promotes the highest standards for product quality
  • Develop and/or manage quality programs and training, complete with tools and processes that support an operational excellence environment and ensure compliance with all company and Federal audit requirements.
  • Manage existing and create new, if necessary, quality gates to ensure incoming inspection, sub-assembly and finished product manufacturing are in compliance and control.
  • Serve as a team member and leader to provide quality expertise to other manufacturing functional teams
  • Work cross functionally with all personnel to promote understanding and cooperation for the quality agenda
  • Lead technical teams to efficiently implement system improvements across multiple departments (engineering, quality, manufacturing, etc.)
  • Work with all levels of the organization to create open communication, share information and knowledge, and maintain a positive working environment focusing on system improvements and culture change
  • Provide regular reports of data and actions to measure progress against the site objectives
  
  
  
  

• Project Based Continuous Improvement (15%)
  
  
  
  • Suggest methods for improving product quality, design, or manufacturing processes.
  • Develop and implement training programs and best practices required to maintain high quality standards.
  • Effectively utilizing lean and engineering methodologies, tools, root cause analysis and waste reduction with a bias for action
  • Establish KPI's and score carding/tracking mechanisms to ensure continuous improvement.
  • Manage existing and create new, if necessary, quality gates to ensure, sub-assembly and finished product manufacturing are in compliance and control.
  • Drive the improvement of processes and systems in the plant and implement programs that will have continuing long-term benefits
  • Work with Program Managers to create timelines, create progress reports, and manage all program elements including proactive communications regarding initiatives
  
  
  
  

• Other (5%)
  
  
  
  • Support all quality and regulatory inspections and audits, as well as the completion of all action items in a timely manner.
  • Perform other duties as assigned.
  
  
  
  

Minimum Requirements

• Bachelor's Degree in engineering, a technical or scientific discipline; and/or equivalent combination of education and experience (Master's preferred)
• 4-6 years' experience in the FDA regulated environment.
• Experience in Quality in an FDA regulated industry.
• Successful experience in factory level quality, production and / or maintenance management.
• Good analytical and problem-solving skills.
• High level of attention to detail and accuracy.
• Leadership and mentoring skills.
• Effective verbal and excellent technical writing skills.
• Ability to communicate and work effectively at multiple levels within the organization.
• Excels at generating and maintaining organized and accurate records.
• Able to work effectively in a high-stress, high-energy environment.
• Able to make effective decisions quickly based on vague or imperfect information.
• Knowledge of applied statistics (sampling plans, capability analysis, population comparison, confidence analysis etc.).
• Ability to create and maintain professional relationships within all levels of the organization (peers, work groups, customers, supervisors).
• Ability to work independently and as a member of a team.
• Flexibility to operate and self-driven to excel in a fast-paced environment.
• Capable of multi-tasking, highly organized, with excellent time management skills.
• Proficient in Statistical Software for data analysis (Minitab preferred).

Supervision/Management Of Others:

• Supervise a team of engineering professionals, make employment decisions (hire, promote, coach, develope), as well as performance management.

Internal and External Contacts/Relationships

• Work at the Merrimack location while collaborating with all other Getinge's sites.

Environmental/Safety/Physical Work Conditions

• Ensures environmental consciousness and safe practices are exhibited in decisions.
• While performing the duties of this job, the employee is regularly required to sit, stand, and walk.
• Employee must occasionally lift and/or move up to 50 pounds.
• Employee must be comfortable working in a Clean Room Environment.
• May work extended hours during peak business cycles.

Annual salary of 115K - 145K depending on experience with 15% STIP

#LI-YA2 #LI-Hybrid