at Terumo BCT
Posted on Sep. 7, 2016
QUALITY RISK MANAGER
The Quality Risk Manager will develop and oversee Quality Management System related activities for Risk Management to ensure alignment and appropriate integration with the company's quality system procedures and processes. The Manager will play an integral role in designing and implementing quality systems to interface with multiple functional areas from I&D, clinical and scientific, operations, regulatory and quality to support the successful development, transfer, sustaining, and post market monitoring activities of all product lines, including both new product platforms and enhancements to existing products.
* Responsible for Risk management procedures, quality plans and resolving risk based non conformances.
* Develops and implements risk based strategy for procedures and processes across the company as they relate to Verification and Validation activities, acceptance criteria, production processes and controls including material/supplier control, CAPA/post market activities, and regulatory changes and impacts.
* Ensure alignment of hazard analysis across documentation for consistent decision making and actions across all functional areas.
* Ensure interface throughout the product realization process and during the entire product life cycle including post-market surveillance.
* Liaise with clinical affairs, quality and regulatory compliance departments to ensure appropriate monitoring and feedback of post market data. Participate on design review teams and provide interactive feedback and assist in the development of supporting documentation.
* Review and approve Engineering Change Orders (ECOs). Assist in the development and updating of internal operating procedures.
* Designs work flows and implements processes and procedures to ensure compliance with quality processes across multi-functional departments within the company procedures.
* Pursues the proactive development of new and existing business processes beyond product quality management.
* Ensure that the Quality Management System is established, implemented and maintained for effectiveness in accordance with applicable regulations, standards and or regional requirements (ISO 13485:2003, ISO 14971, MDD, CMDR, FDA Quality System Regulations).
* Ensures QA documentation is maintained and reviews controlled documentation for Risk Management and Post market Surveillance processes as required by regulatory agencies and internal stakeholders.
* Works with others to develop and implement effective training programs related to Risk Management and Post Market Surveillance to achieve and maintain quality system and regulation awareness, ISO certifications and Quality System compliance.
* Researches, sets and reports appropriate Design Quality metrics to monitor and improve the performance of the Quality System. Identify and resolve issues in a timely manner.
MINIMUM QUALIFICATION REQUIREMENTS
* Bachelors of Science or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
* Bachelors of Science degree or Master of Science degree, in Engineering, preferred.
* Minimum 10 years experience.
* Preferred minimum of 7 years experience involving US FDA Class II or Class III medical devices.
* Experience with implementation and execution of Risk Management Activities (e.g. ISO 14971:2012, ISO 62304, etc)
* Experience in interfacing with global regulatory agencies (USFDA and or Notified Body inspections, audits or other similar regulatory body inspections).
* Comprehensive knowledge of U.S., European and other international regulations, standards and guidance applicable to medical devices (e.g. ISO 13485, 21 CFR 803, MDD, MEDDEV 2.12, MHLW, etc.).
* Experience over a wide range of product-based Quality activities, including design control, process validation, production quality, statistical methods, and Corrective and Preventative Action (CAPA) strongly preferred.
* Experience with international standards related to medical design and manufacturing is preferred.
* Experience with Essential Design Outputs and Critical component criteria preferred.
* Ability to evaluate, analyze and summarize large volumes of data and technical material efficiently.
* Ability to function well individually as well as participating in and leading cross-functional teams.
* Close involvement in more than one complete medical device product development cycle from concept through production and field service.
* Must have expert knowledge in Risk Management and Post Market Surveillance regulatory requirements.
* Proven ability to solve practical problems in a collaborative manner which yields effective compliance with QMS and external standards while allowing for the use of efficient and flexible implementation approaches.
* Proven ability to interact broadly within the entire organization, including influencing other members in matters of significance to the risk management and post market processes.
* Demonstrated ability to organize and motivate cross-functional and multi-facility teams to meet quality goals.
* Possesses a strong drive to seek and solve existing or latent problems. Maintains a consistent and resolute willingness to take ownership and accept responsibility for risk management and post market processes.
* Proven ability to read and interpret documents of significant complexity, including external standards, design inputs, verification/validation protocols, and clinical studies.
* Ability to hire, trains, and develop team members.
* Knowledge and use of relevant PC software applications and skills to use them effectively.
* Demonstrated ability to communicate effectively both verbally and in writing.
An equivalent competency level acquired through a variation of these qualifications may be considered.
Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.
The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
ADDITIONAL PHYSICAL REQUIREMENTS
* Some international travel will be required (10 %)
We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.
We maintain a drug-free workplace and perform pre-employment substance abuse testing and background verification checks. As of January 1, 2017 the Terumo BCT Lakewood, Colorado location will be a tobacco-free workplace.