Quality Engineer

---

Job description

Will consider both local and remote candidates.

Preference to be given to candidates with at least 1-year of industry experience in medical device or bio-tech industry. Candidate must have industry-experience of 1 to 2 years; must be proficient in Microsoft Word and Excel and should have appetite for documentation and data analysis. There is a potential for this position to turn into permanent role if we end up hiring a solid consistent performing associate.

JOB SUMMARY
Early career role responsible for collection, analysis and reporting of Quality Data to assist with Management Review content development. This position is responsible for reviewing and processing the quality data (e.g. complaint data, CAPA etc.) and ensuring documentation is in compliance with established and formalized procedures.

Works on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required. Normally receives general instructions on routine work assignments, detailed instructions on new assignments. Can perform work assignments independently with minimum supervision.

PRIMARY RESPONSIBILITIES

•Passionate for data extraction, visualization and analysis using excel (or any other statistical tools), report writing and power point slide preparation
•Reviews data between multiple databases and exported spreadsheets.
•Ability to document statistical-based data analysis
•Assures the data integrity of all output via appropriate verification and validation
•Interfaces with multiple functions and departments.
•Performs tasks of moderate complexity, within planned schedules and timelines.
•Contributes to the completion of milestones associated with specific projects.
•Ensures compliance to Quality System Requirements and post market surveillance procedures.
•Identifies and escalates questions/issues to the attention of direct manager and provides possible resolutions
•Agility to quickly learn International Regulatory requirements (e.g. IVDR, Health Canada) and adapt accordingly

MINIMUM QUALIFICATIONS:
•Bachelor's in Engineering (Electrical, Computer Science, Biomedical, etc.) or BS in Mathematics or Statistics

DESIRED KNOWLEDGE/SKILL/EXPERIENCE:

•Proficient in basic statistics and data analysis using Microsoft Excel
•Proficient in editing documents using Microsoft Word
•Proficient with Microsoft PowerPoint slide preparation
•Must have at least a year or two industry experience - preferably in medical device or bio-tech
•Excellent communication - written and verbal - effective cross-functional collaboration
•Ability to multi-task and on-target delivery of tasks with minimal supervision
•Effective analytical, technical, and problem-solving skills.