Sr. Quality Engineer, MES

Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $5+ billion in sales, 20,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.

Job Summary

The Manufacturing Execution System (MES) Senior Quality Engineer position will work closely with the IT, Operations, Validation, and Engineering, teams to ensure that projects (new MES deployments, sustaining, and/or optimization) related to MES are implemented compliantly and in a timely manner. This role will support production to drive continuous improvement. The position will also ensure compliance to Terumo’s quality policy, develop requirements, revise/create procedures, develop validation test cases, and maintain the integrity of the electronic device history record (eDHR

Job Details/Responsibilities

• Act as an integrated MES team member to support new MES deployments, sustaining, and optimization projects
• Lead cross functional projects with understanding and application of engineering principles 
• Develop and/or revise complex MES requirements documentation, procedures, control plans, PFMEAs, and training materials
• Maintain the compliance of the MES, the integrity of its validated state, and the eDHR
• Proactively identifies requirements gaps, investigates, and implements best-in-class Quality Engineering practices and solutions
• Coach/mentor fellow team members on best-in-class Quality Engineering and Computer Systems Validation practices and solutions
• Independently lead projects for the MES team.
• Present high-level overviews or presentations to executive leadership on MES optimization information.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues related to MES
• Develop MES validation test cases and support Software Verification & Validation activities
• Support the Elkton, MD site as a subject matter expert (SME) related to MES and the integration with Product Life Cycle Management
• Develop training strategy plans and support MES team to deliver training on MES processes
• May need to work across shifts during some phases of MES deployments
• Perform other job-related duties 
   

Knowledge, Skills and Abilities (KSA)

• Knowledge of national and international regulations applicable to medical devices including Quality System Regulations, 21 CFR 820, 21CFR 803 and 804 (MDR regulations), Canadian Medical Device Regulations, ISO 14971, ISO 13485, and MDD 93/42/EEC
• Excellent communication skills; verbal and written
• Ability to lead or work as a team member on cross-functional teams and with employees within all levels within the facility
• Excellent computer skills and working knowledge of Microsoft Office Suite
• Strong problem-solving and critical-thinking skills
• Detail and results-oriented; self-motivated and driven to work independently 
• Ability to multitask, prioritize, and provide deliverables within the required timeframes
• Excellent organizational and time management skills 
   

Qualifications/ Background Experiences

• Requires Bachelor’s degree (4 years) or higher from an accredited course of study, in engineering, engineering technology, computer science or technical field with relevant experience
• Requires six - eight years experience in a medical device or highly regulated industry
• Experience working in a manufacturing environment preferred
• Experience with implementing and maintaining a Manufacturing Execution System / eDHR preferred
• Experience with Change Management, Computer System Validation, and HP ALM preferred

It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protect