Quality Systems Specialist (Return Goods Laboratory)

TERUMO BCT, INC; Lakewood (CO); On-site; USD 68,000 - 86,000; Full time

Job summary

An established industry player is seeking a Quality Systems Specialist for their Return Goods Laboratory. This pivotal role involves conducting thorough investigations of product complaints and analyzing returned goods to identify root causes. You will work closely with various teams to drive continuous improvement initiatives that enhance product quality and customer satisfaction. If you possess a solid background in quality systems and exceptional problem-solving skills, this opportunity is perfect for you. Join a company dedicated to advancing healthcare and making a difference in patients' lives every day.

Benefits

Group medical plans

Dental plans

Vision plans

Wellness program

Life insurance

Disability coverage

401(k) plan with matching contribution

Vacation and sick time programs

Voluntary programs (e.g., pet insurance)

Qualifications

• Bachelor's degree or equivalent experience required.
• Minimum 4 years experience in a manufacturing environment preferred.

Responsibilities

• Conduct in-depth complaint investigations and analyze returned goods.
• Collaborate with cross-functional teams to enhance product quality.
• Manage a Quality Survey system and coordinate quality projects.

Skills

Time management

Problem-solving

Manufacturing protocols knowledge

Analytical techniques

Effective communication

Technical writing

Project management

Knowledge of FDA regulations

Education

Bachelor’s degree

Tools

Microsoft Outlook

Microsoft Teams

Microsoft Word

Microsoft PowerPoint

Microsoft Excel

Job description

Select how often (in days) to receive an alert:

Quality Systems Specialist (Return Goods Laboratory)

Date: Apr 17, 2025

Location: Lakewood, CO, US

Requisition ID: 33656

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.

As a Quality Systems Specialist, you will take on a pivotal role in the Return Goods Laboratory, focusing on ensuring product excellence. You will conduct in-depth complaint investigations and analyze returned goods to uncover root causes and patterns. By collaborating with cross-functional teams, you will champion continuous improvement initiatives that enhance product quality and elevate customer satisfaction. If you have a solid background in quality systems, exceptional problem-solving skills, and a drive to achieve outstanding results, we encourage you to join us in upholding our commitment to excellence.

ESSENTIAL DUTIES

• Organize and manage a Quality Survey system to provide requested feedback to customers.
• Serve as the project coordinator for a given Quality System, managing meetings which includes creating presentations, monitoring trends, analyzing data reports, ensuring timeliness on reports, writing/communicating meeting minutes, tracking action items, and presenting data to meeting attendees.
• Work closely with quality management, manufacturing, engineering, regulatory affairs, and other functional groups on regulatory as well as quality system compliance issues.
• Develop or participate in the development of solutions to problems of moderate to intermediate complexity. Interpret, execute, and recommend modifications to operating policies where appropriate.
• Provide accurate and timely turnaround on investigations, surveys, trend reports, and other activities. Utilize technical writing skills to create or edit reports and communicate effectively to management regarding those reports.
• Organize and manage projects that typically will require ingenuity and evaluation as well as vendor and/or customer contact.
• Fulfill FDA and international regulatory requirements relevant to each project such as GMP, IDE, PMA, 510(k), and ISO Standards.
• Perform Periodic Review of Documents: manage or evaluate company Standard Operating Procedures (SOPs) intended to assure compliance with applicable global regulatory requirements and standards.
• Comfortable directing or supporting internal or external audits (front room and backroom duties).

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.

Experience

Minimum 4 years experience, with experience in a manufacturing environment preferred.

Skills

• Time management and flexibility.
• Demonstrated ability to routinely diagnose problems and recommend solutions through teamwork, failure mode analysis, and other analytical techniques.
• Knowledge of manufacturing protocols, statistical tools and methodology, and continuous improvement techniques.
• Ability to communicate effectively both verbally and in writing.
• Knowledgeable in FDA and international regulations relevant to each project, i.e., GMP, IDE, PMA, 510(k), and ISO.
• Work assignments require the development of in-depth engineering or technical writing skills.
• Ability to organize and manage a multitude of projects.
• Knowledge and use of relevant PC software applications (Outlook, Teams, Word, PowerPoint, Excel, etc.) and skills to use them effectively.

-Or-

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

LOCATION

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

TRAVEL

May be required to travel domestically on a rare occasion.

PHYSICAL REQUIREMENTS

• Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Target Pay Range: $68,500.00 to $85,700.00 - 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: 7.0%

At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with various well-being, work-life and recognition programs which support 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, as well as various 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.

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.