at Terumo BCT
Posted on Sep. 1, 2016
Provides leadership to the company in the process of building a global compliant Quality Management System by applying an advanced level of understanding of international regulatory requirements and industry standards.
* Manage design and implementation of global quality management system in accordance with department, regulatory, and professional standards for compliance.
* Facilitates and coordinates workstream activities and tasks to support the execution of the QMS design project plan.
* Manages scope and schedule for the workstream and drives to quality on time completion.
* Ensures proper assignment and coordination of extended team and resources per project execution plan.
* Tracks status and metrics on the project delivery and value; escalates to functional management upon identification of deviations (or potential deviations) from plan.
* Effectively manages communications, expectations, and interactions with all departments and internal stakeholders.
* Delivers informative, well-organized presentations on project status and selected project topics.
* Effectively utilizes each team member to accomplish the project objectives.
MINIMUM QUALIFICATION REQUIREMENTS
Bachelor's degree or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
* Minimum 5 years experience.
* Preferred minimum 7 years experience in Quality Assurance and or Regulatory Affairs, involving US FDA Class II or Class III medical devices including knowledge & experience of applying global device laws & regulations for adverse event reporting and product recalls.
* Minimum 2 years supervisory experience.
* Preferred training in FDA Quality System Regulation and ISO 13485.
* Experience implementing and validating enterprise level software applications preferred.
* Candidates with experience in embedded product software, stand alone software, processing equipment software validation preferred.
* Solid understanding of part 11
* Knowledge and experience interpreting and applying global regulations and standards for Quality Management System.
* Knowledge of U.S. and international medical device regulations and standards (CFR 820, MDD and ISO 13485).
* Strong interactive skills in cross functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross functional team member, team behavior, and support for subordinates, quality specialists, and management.
* Solicits and accepts the ideas of others, as well as actively contributes to an environment conducive to open communication.
* Capability to interact with diplomacy and tact while maintaining appropriate assertiveness.
* Demonstrated ability to communicate effectively both verbally and in writing.
* Knowledge and use of relevant PC software applications and skills to use them effectively.
* Must be detail oriented, well organized and able to work independently and in teams.
* Demonstrated ability to lead people and get results through others.
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
* Requires travel based on business needs.
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.