Quality Systems Specialist

Requisition ID:  31622  

 

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. 

JOB TITLE:  Quality Systems Specialist

 

 

JOB SUMMARY

Working under very general supervision, provides quality support for the global audit and compliance team by assisting management in complying with worldwide regulatory requirements.  Performs investigations,  reviews records, assists with audit activities, helps manage ISO certification and registration, and provides other services to this end.

 

 

ESSENTIAL DUTIES

• Works independently to accomplish established objectives and performs varied quality/regulatory activities.
• Partners closely with manufacturing, engineering, and other functional groups on regulatory compliance issues.  Develops or participates in the development of solutions to problems of moderate to intermediate complexity. 
• Maintains reports that are accurate and concise.
• Designs and performs routine testing, project experiments, and analysis of data on an independent basis. Reports results.
• Fulfills FDA and international regulatory requirements relevant to each project such as GMP, IDE, PMA, 510(k), and ISO.
• Assists the global audit team with audit activities
• Helps to manage ISO certification and registration
• Extreme focus on quality and compliance

 

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 5 years experience.

Experience in a manufacturing environment preferred.

 

Skills

• 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.
• Demonstrated 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.
• Knowledge of relevant PC software applications and skills to use them effectively.

-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 Physical Requirements

Must be able to travel based on business need.

 

 

Target Pay Range:  $65,600.00 to $82,000.00  -  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 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 pers