This position represents the quality organization as QA for design changes to existing manufactured and marketed devices. The Design Quality Engineer (QE) ensures compliance to QMS and design control change process and procedures, and ensures ongoing maintenance of product documentation. They ensure adherence to customer and regulatory requirements are demonstrated and help to ensure successful transfer of the design changes to the product.
Work requires originality and judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures, and criteria. Performs work which requires a broad knowledge of precedents in the specialty area and a good knowledge of principles and practices of related specialties. Duties are assigned to provide experience and familiarization with engineering methods, independent thinking, and company practices and policies.
Collaborate closely with I&D, operations, and project leads to implement product design changes
Help define, then articulate and support the Design Quality role within the design change process
Ensure compliance to QMS and design change processes and procedures
May help facilitates and support risk management activities such as FMEA and pFMEA
Contribute to the development and refinement of Design Change policies and procedures to ensure they comply with appropriate standards, regulations, and industry best practice
Anticipate roadblocks, provide direction for navigating the quality system and supporting applications.
Take an active role in Design Reviews to assess quality and compliance
Responsible for accurate, independent evaluation of Design History File documentation and overall compliance to the Quality System
Receives assigned total project leadership responsibilities on a portion of major significant projects and will be given total management responsibility for smaller projects.
Manages and provides leadership for the functional group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
Implements and understands FDA or regulatory requirements as necessary.
Applies technology principles to multiple tasks. Working knowledge of cross-functional and related technical areas.
Highlights risks and understands how to approach and complete tasks, avoiding serious delays and considerable expenditure of time and resources.
Advises team members pro-actively on technical ideas and promotes skill development of team work.
Interacts with peers across projects to secure resources and commitments.
Handles frequent inter-organizational and outside customer contacts. Represents the organization in providing solutions to difficult technical issues associated with specific projects.
Follows technical specification requirements and provides feedback on various technical processes and procedures.
Presents effectively complex technical information/analysis, and responds to questions from technical staff members and management.
Works cooperatively and effectively within a team environment to achieve common goals and results, often influencing the outcome of the team(s).
OTHER DUTIES AND RESPONSIBILITIES
Work direction responsibility may include technicians and junior engineers.
May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.
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.
Bachelor of Science Degree in Engineering, preferred.
Minimum 4 years experience.
Two years of GMP manufacturing experience required.
Requires demonstrated skills in technical innovation, technical leadership, mechanical and or chemical engineering, fluids engineering, and cellular biology.
Strong interactive skills in general communication, 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, junior engineers, technicians, and management.
Strong technical problem solving skills.
Mechanical and electronic ability aptitude to assist with equipment trouble-shooting.
Understanding of and adherence to GMP practices and FDA regulations.
Knowledge and ability to implement FDA or regulatory requirements as necessary.
Demonstrated ability to communicate effectively both verbally and in writing.
Knowledge and use of relevant PC software applications and skills to use them effectively.
An equivalent competency level acquired through a variation of these qualifications may be considered.
General Labor Environment requirements include: use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment.
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.
Join Terumo BCT, formerly known as CaridianBCT, as we unlock the potential of blood. We are the world leader in blood component technology, delivering products, services and solutions for customers and their patients worldwide. Through collaboration with our customers and a commitment to innovation, we are the only company with the unique combination of apheresis, manual and automated whole blood ...processing and pathogen reduction technologies coupled with robust technology, innovation and core competencies in therapeutic apheresis, cell collections and cell processing.
As the largest medical device manufacturing company headquartered in Colorado we operate in 120 countries with more than 2,600 associates around the world.
Our company has been voted and recognized as a:
• “Best Places to Work” employer by The Denver Business Journal and 5280 Magazine (2003)
• Top five world-class training organization by Training and Development Magazine (2011 & 2012)
Our award-winning culture embraces:
• Leading technology through innovation and R&D
• Wellness programs
• Commitment to quality
• An environment that values and respects your individual contributions
• A philosophy of intentional growth
Each associate has a positive impact on our future by:
• Connecting to the lives of the patients we ultimately serve
• Growing through professional and leadership development activities
• Sharing company success through incentive plans
If you are the best at what you do, we invite you to work with us now!