Recent Searches

You haven't searched anything yet.

1 Senior Manager, Design Control & Risk Management Job in Lakewood, CO

SET JOB ALERT
Details...
Terumo BCT
Lakewood, CO | Full Time
$144k-180k (estimate)
2 Months Ago
Senior Manager, Design Control & Risk Management
Terumo BCT Lakewood, CO
$144k-180k (estimate)
Full Time | Business Services 2 Months Ago
Save

sadSorry! This job is no longer available. Please explore similar jobs listed on the left.

Terumo BCT is Hiring a Senior Manager, Design Control & Risk Management Near Lakewood, CO

Requisition ID: 31838

At Terumo Blood and Cell Technologies, our 7,000 global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world.

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient's life every second of every day and are committed to continuing to increase the number of patients we serve.

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Consider joining our team and unlock your potential.

Provides overall global quality leadership within Terumo BCT to monitor, maintain and continuously improve global processes and supporting technology to ensure successful product launches and compliance to all applicable regulations for Terumo BCT products with respect to Design Controls and Risk Management. The primary responsibility of the position is to lead the global, cross-functional organization to be compliantly effective and organizationally efficient in the use and maintenance of Global Design Controls and Risk Management processes and use of applicable technology.

ESSENTIAL DUTIES

  • Accountable to maintain the integrity of Global Processes for Design Controls and Risk Management with company, regulatory and professional standards, through monitoring, continuous improvement and implementation of process and applicable supporting technology.
  • Communicates on all levels with senior management, including technical, strategic, and business.
  • Maintains strong process orientation and drives culture of accountability and continuous improvement mindset.
  • Serves as expert for global regulations, standards and processes within area of responsibility.
  • Responsible for maintaining and evaluating needs across the organization to ensure global compliance of Design Controls and Risk Management activities with all applicable regulations for Terumo BCT products.
  • Responsible for communication and coordination with business functions, global QMS teams and Site Leadership for implementation, auditing, teaching and coaching of process and applicable technology changes.
  • Demonstrate strong, influential leadership to effectively manage, resolve and/or escalate QMS-related implementation and/or global interpretation issues in a timely fashion for quick resolution.
  • Delivers purposeful, well-organized presentations on changes, issues, resolutions and forward-thinking vision for global Design Controls and Risk management processes and associated supporting technology.
  • Effectively works with all Process Owners and QMS Governance leader to ensure a seamless Quality Management System implementation, interpretation and understanding by the Terumo BCT organization.
  • Develops and maintains metrics for Design Controls that support the business and management review needs.
  • Manages scope and schedule for Design Controls updates and associated training and drives quality, on-time completion for implementation and ongoing changes across the TBCT cross-functional organization.
  • Lead Design Control work and utilize influence skills at all levels of the organization; coach, mentor and teach peers and reports as well as successfully teaching and influencing leadership teams towards efficient compliance and assisting with functional excellence approaches.
  • Oversees the work of the Design Controls and Risk Management teams.

MINIMUM QUALIFICATION REQUIREMENTS

Education

  • 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.

Experience

  • Minimum 7 years' experience in Quality, Regulatory Affairs, Manufacturing or Engineering within regulated industry (e.g. medical device, pharmaceutical).
  • Knowledge and experience interpreting and applying global regulations and standards for Quality Management System.
  • Demonstrated experience working with, influencing and or leading global teams.
  • Experience with FDA inspection and other regulatory/customer audits.
  • Knowledge and experience working within a Quality Management System, demonstrated ability to understand andexplain the basics of how the Quality Management System works integration of QMS elements and expectations of the organization to meet QMS requirements.

Skills

  • Demonstrated ability to develop and implement compliant, efficient processes.
  • Strong communication skills within cross functional teams, active participation and effective influence skills, mentoring and acceptance of constructive criticism, technical leadership, project management, coordination with cross functional team members and support for subordinates, junior engineers, technicians, and management.
  • Demonstrated ability to learn and apply new technology to business/QMS processes to the level of supporting other members of the organization; ability to explain technology needs to the IT organization for continuous technology improvements.
  • Ability to lead a team, with varying perspectives, to quick consensus and support.
  • Solicits and accepts the ideas of others, as well as actively contributes to an environment conducive to open communication.
  • Ability and willingness to work on multiple topics to meet business needs.
  • Demonstrated ability to effectively lead and manage peers, as needed to implement improvements to QMS processes and applicable tools.
  • Demonstrated ability to develop and maintain the overall project vision and strategy while managing the tactical details and activities.
  • Demonstrated Growth Mindset - willingness to experiment, value progress and learn from others, along with intellectual curiosity.
  • Ability to manage conflicts; to read situations quickly, to lead by influence, leverage opportunities, find common ground and achieve cooperation for business benefit.
  • Knowledge and use of relevant PC software applications, PowerBI and skills to use them effectively.
  • Able to communicate the business and customer impact of quality regulations with a bias for action in addressing gaps.

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.

PHYSICAL REQUIREMENTS

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 Requirements

Requires travel based on business needs.

Target Pay Range:$145,800.00to$182,200.00 -Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data
Target Bonus on Base:20.0%

At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family.Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more.To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates.For us, it's about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.

  • Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.
  • In 2019, Terumo Blood and Cell Technologies reached $1 billion in revenue.
  • We employ nearly 7,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.
  • We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries.
  • Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare.
    • Respect - Appreciative of others
    • Integrity - Guided by our mission
    • Care - Empathetic to patients
    • Quality - Committed to excellence
    • Creativity - Striving for innovation
  • We contribute to the Leukemia and Lymphoma Society (LLS), raising $1.3 million USD since 2007.

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, gender identity or expression, 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.

Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment.Our Colorado campus locations are tobacco-free workplaces, and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification.

Job Summary

JOB TYPE

Full Time

INDUSTRY

Business Services

SALARY

$144k-180k (estimate)

POST DATE

02/27/2024

EXPIRATION DATE

04/15/2024

WEBSITE

palmer-gang.com

HEADQUARTERS

Aurora, CO

SIZE

<25

INDUSTRY

Business Services

Show more

Terumo BCT
Full Time
$77k-104k (estimate)
Just Posted
Terumo BCT
Full Time
$28k-34k (estimate)
Just Posted
Terumo BCT
Full Time
$118k-152k (estimate)
Just Posted