Audit manager Jobs in Denver, CO

Requisition ID : 33402

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. For Terumo, for Everyone, Everywhere.

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. Advancing healthcare with heart.

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. Join us and help shape wherever we go next. You create your future and ours.

We are seeking an Audit Manager to join our team in Lakewood, Colorado. In this critical role, you'll oversee internal, external, and supplier audits, serve as a key contact for regulatory compliance, and champion continuous improvement initiatives. With responsibilities ranging from managing cross-functional teams and interfacing with global regulatory authorities to mentoring and developing an audit team, you'll be instrumental in ensuring compliance with U.S. and international medical device regulations. Bring your passion for quality, strong leadership skills, and expertise in FDA Quality System Regulation and ISO 13485 to make a tangible impact in advancing patient care.

ESSENTIAL DUTIES

• QMS area of ownership, management, and responsibility : Audit (internal, external, supplier).
• Serves as Audit expert and main point of contact for regulatory / compliance issues.
• Acts as the policy / procedure owner for area(s) of responsibility, ensuring they are compliant and effective and ensures the cross-functional organization understands and supports QMS Audit activities as needed.
• Executes their QMS area(s) in accordance with governing internal policies / procedures and external standards and regulations. This likely includes : generation and approval of annual schedules, execution to schedule, approval of plans or reports, follow up on action items, facilitation of discussions with participants and stakeholders to ensure success and compliance.
• Supports the remediation of internal site audits and regulatory audits.
• Monitors and reports the health of the QMS areas(s) within their area of responsibility, and provides metrics to management as required, including any governing oversight boards. Identifies and implements continuous improvement opportunities within their area(s) of responsibility.
• Serves as Subject Matter Expert and Process Owner for their QMS area(s) of responsibility during audits and inspections.
• Acts as a Audit host or backroom leader when requested.
• Influences the organization in quality objectives, prioritization and resourcing decisions as necessary.
• Manages team of direct reports in support of the above (as applicable).
• Manages and provides operational leadership for the audit team's development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
• Acts as an internal champion for quality initiatives aimed at improving business systems and compliance; may be the primary representative of Quality group on projects.
• During audits and inspections, interfaces with global regulatory authority, notified body auditors and provides general support for the Quality group.
• Interfaces with QMS area owners and project teams from other Terumo BCT locations, regions, and corporate.

MINIMUM QUALIFICATION REQUIREMENTS

Education

Bachelor's degree in a science related field (Science, Technology, Engineering or Mathematics).

Experience

Skills

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

LOCATION

Lakewood, Colorado - Hybrid - Open to candidates willing to relocate to the area.

PHYSICAL REQUIREMENTS

Target Pay Range : $120,400.00to$150,600.00 -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 : 10.0%

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.

Respect - Appreciative of others

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.