Quality Engineer- Investigations
Mississauga, Ontario, Canada
1d ago

Baxter International Are you looking for a career that matters?

We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today.

We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them.

We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.

Summary This position has primary responsibility for investigation, review, and completion of all Quality Engineering complaint issue analysis tasks utilizing various quality system inputs.

Review individual complaints and associated service data to determine risk level and complete investigation into the as determined problem code and cause codes for each complaints.

Analyze data from various quality inputs (including but not limited to : Field Corrective Action (FCA), Complaints, FDA Medical Device Reports (MDR), etc.

to determining trends and systemic issues. Prepare and issue reports based on information analysis.

Review existing investigation reports and identify gaps for GMP compliance. Develop strategies and plans to close the gaps in an efficient and technical manner.

Develop and communicate expectations for quality performance, continuous improvement and process controls for marketed products.

Monitor and drive corrective action and continuous improvement activities that directly impact performance measures by performing primary investigations, conducting data analysis, and implementing corrective actions.

Conduct or lead corrective and preventive actions in manufacturing using formal problem solving tools and documentation.

Support CAPA and maintenance activities for existing product lines.

Recommend and / or support projects for improvements to the quality system as approved by management.

To perform this job successfully, and individual must be able to perform each essential duty satisfactorily.

Medical Device Experience with knowledge of 21CFR820 preferred.

Investigational research skills

Experience with any statistical software packages (Minitab a plus)

Desired experience in the medical device industry in the development and deployment of Quality Systems, and process controls, and continuous improvement methods.

Knowledge and working application of FDA cGMP; ANSI / ISO / ASQC requirements; CMDAS (optional).

Knowledge and working application of reading and understanding blue prints and technical drawings.

Demonstrated strong analytical problem solving (Root Cause Investigations.

Display a solid technical understanding of engineering principles and procedures (e.g. CAD and its application or scheduling a series of technical tasks utilizing software-based tools).

Computer competency in Word, Excel, Power Point, Minitab, Access and databases.

Ability to multi-task and methodically manage projects.

Education / Experience Required :

A Bachelors of Science in Engineering

1-3 years of Medical Device experience

Physical Demands :

Able to exert up to 10 pounds of force occasionally.

Able to sit, stand, walk throughout the work day.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability / handicap status or any other legally protected characteristic.

EEO is the Law EEO is the law - Poster Supplement Pay Transparency Policy

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-

mail to Americas TTA baxter.com and let us know the nature of your request along with your contact information.

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