Manager, Production Quality Engineering at Getinge

Merrimack, New Hampshire, United States -

Full Time

Start Date

Immediate

Expiry Date

07 Feb, 26

Salary

145000.0

Posted On

09 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Engineering, FDA Regulations, Root Cause Analysis, Lean Methodologies, Statistical Software, Analytical Skills, Problem Solving, Leadership, Communication, Team Collaboration, Manufacturing Processes, Quality Management System, Training Development, Continuous Improvement, Data Analysis, Time Management

Industry

Medical Equipment Manufacturing

Description

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. 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 About us  With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.   Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: Health, Dental, and Vision insurance benefits 401k plan with company match Paid Time Off Wellness initiative & Health Assistance Resources Life Insurance Short and Long Term Disability Benefits Health and Dependent Care Flexible Spending Accounts Commuter Benefits Parental and Caregiver Leave Tuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

Responsibilities

The Manager of Production Quality Engineering oversees quality engineering programs and processes in a manufacturing plant, ensuring compliance with FDA regulations and managing quality assurance personnel. This role involves cross-functional collaboration to improve product quality and implement system improvements.