Manager, Quality Engineer PMS - Elkton, United States - Terumo

Description

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 Manager Quality Engineering, Post Market Surveillance will manage the Post Market Complaints Engineering Team and will be responsible for the complaint engineers completing medical device complaint investigations, product evaluations and the development of process strategies, procedures, goals, and metrics to ensure ongoing compliance to the overall complaint handling process and Terumo Medical Corporations policies and procedures. This management position includes responsibility for planning and coordinating the daily complaint engineering activities, accountability for managing the complaint engineers' time efficiently and effectively to meet specific quality metrics related to complaints and providing advice and guidance to the complaint engineers on how to execute their daily responsibilities.

Job Details:

• Promote a work environment of continuous improvement that supports Terumo's Quality Policy, Quality System and Global Regulations.
• Accountable for the Post Market Complaints Engineering Team and managing the product evaluations process in compliance with applicable regulations and standards such as FDA Quality System Regulation, 21 CFR Part 820, ISO 13485:2016, EU Medical Device Regulation (MDR), etc.
• Serves as the system architect for EU MDR compliant Post Market Complaints Engineering system
• Works towards creating and sustaining a risk-based process for complaints escalations and resulting corrective actions.
• Work in a team environment with members of the Quality Assurance group on achieving team metrics requirements. Schedules work for the team to meet Corporate, Team and Individual performance metrics. Monitors progress of and provide support on special projects
• Oversees the day-to-day operations within the PMS Complaint Investigations (i.e. daily interaction and communication of staff, setting goals and objectives, planning schedules, lab equipment calibration and ordering etc.).
• Promote the engagement of the complaints engineering personnel and ensure they have clear expectations with appropriate tools and information to manage the timely flow of product evaluations and assessment of risk while maintaining KPIs for PMS&V.
• Engages with, and guides as necessary, other manufacturing sites, New Product Development, quality and sustaining engineering, and other technical resources to ensure thorough and accurate investigations and drive the initiation of NC and CAPA when appropriate.
• Support the Post Market Complaint investigations, ensuring product safety and optimizing patient care by ensuring timely, thorough investigations and resolutions of post-market quality and safety issues. This support may include leading or directing more-complex investigations when necessary.
• Coordinates with the Adverse Event Reporting Specialists to ensure compliance in FDA and outside US MDR event reporting.
• Implement and maintain a best-in-class post market risk management system and process. Identify risk throughout the product lifecycle with the application of risk management tools.
• Review product evaluation test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives.
• Promote a continuous improvement culture and utilize quality tools and statistical methods that support and comply with TMC's Quality Policy, Quality System and Global Regulations.
• Participate in Quality Management Reviews as requested.
• Coach, mentor, develop and manage staff to meet department goals efficiently and effectively.
• Responsible for timely and effective coordination and/or execution of assigned project activities.
• Generate internal quality documentation such as quality plans, standard operating procedures, and inspection procedures.
• Prepare responses to customers and field associates as necessary per process.
• Support internal and third-party audits with post-market related requests.
• Provide training and support for quality system processes and complaint engineering practices.
• Other duties as assigned.

Position Requirements:

Knowledge, Skills, and Abilities (KSAs)

• Background in GMP Quality and/or Medical Device Manufacturing
• ASQ Certified Quality Engineering (CQE) or similar ASQ certification
• Six Sigma green belt or problem-solving training (DMAIC) preferred
• Expertise with Basic statistical tools, i.e., Minitab, average, standard deviation, process capability to detect post market trends
• Proficient computer skills and demonstrated competence to include word-processing, database applications, and spreadsheet.
• Effective communication skills required
• Strong mechanical aptitude and methodical problem-solving
• Solid understanding of root cause analysis and different quality tools used to solve problems
• Risk Based Thinking and expertise in post market risk management (identification, analysis, evaluation, and treatment)
• Mechanical aptitude skills for device building and/or test set-ups
• Knowledge of statistical tools and their targeted application to medical device (or combination products) post market surveillance
• Demonstration of self-motivation and leadership skills
• Knowledge of Biohazardous Materials and related safeguards and protocols
• Organizational skills as well as time management skills essential for project work and coordinating activities within and across departments.
• Strong understanding of EU MDR regulations as they pertain to Post Market Surveillance

Background Experiences

• Bachelor's degree required or equivalent combination of relevant work experience and education, BS from an accredited university preferred.
• Requires (7) seven years of increasing responsibility and experience in quality assurance environment
• Requires a minimum of one to two years in medical device complaint (post market experience)
• Prior experience must include experience in all of the following:
  • Using Minitab or similar statistical tools for statistical analyses to detect post-market trends
  • Using root cause analysis to perform product failure analysis
  • Post-market risk management experience under applicable government regulations, including 21 CFR 820, ISO 31000, ISO 13485:2016, ISO 14971, ISO 24971, ISO 7870, ISO 9001, and EU regulations
  • Theory and application of various control charts
  • Contributing to corrective action investigations and analysis
  • Enforcing quality of investigative root cause analysis.
• One to two years of auditor experience with certificationpreferred
• One to two years' experience leading or managing others preferred
• Working knowledge and understanding of FDA's QSRs, ISO 13485:2016, MDD, EU MDR, and other national/international regulatory quality system requirements.

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 protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.