Quality Compliance Analyst-MDR focus

at Terumo BCT

Denver, CO

Posted on Sep. 10, 2016

Working under general supervision, provides quality compliance support and analysis for the business by assisting management in complying with worldwide regulatory requirements. Performs daily compliance activites, reviews records, supports audits and continuous quality system improvements efforts.

* Performs varied quality/regulatory activities (ex. Adverse Event Reporting, CAPA, Field Actions, Audits, Document Control) and ensures tasks are completed in compliance with regulatory and internal requirements.
* Maintains quality data and related reports that are accurate and concise.
* Maintains regulatory required records per record retention requirements.
* Designs and performs routine analysis of data and reports results on an independent basis.
* Takes responsibility for fulfilling FDA and international regulatory requirements relevant to daily tasks and each project, such as cGMP and ISO.
* 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 compliance complexity. Interprets, executes, and recommends modifications to operating policies where appropriate.
* Identifies areas where the business can effect quality system improvements.
* May assist in identification, creation, implementation, and maintenance of training for QMS policies and procedures.

Bachelor's degree or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.

* Minimum 2 years experience.
* Experience in a FDA / ISO 13485 regulated environment preferred.


* Demonstrated ability to communicate effectively both verbally and in writIng.
* Proficiency in technical writing.
* Knowledge and use of relevant PC software applications including Microsoft Word and Excel and skill to use them effectively.
* Ability to routinely diagnose problems and recommend solutions.
* Ability to develop knowledge in FDA and international regulations relevant to each project, i.e., cGMP, and ISO.
* Detail oriented.

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

* May be required to travel domestically and internationally based on business need.

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, 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.
We maintain a drug-free workplace and perform pre-employment substance abuse testing and background verification checks. As of January 1, 2017 the Terumo BCT Lakewood, Colorado location will be a tobacco-free workplace.

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