We are hiring Quality Engineers for a leading pharmaceutical company in Scarborough
Location: Sheppard and McCowan
This is a Temporary to Permanent position
To perform this job successfully, an individual must be able to oversee/perform each essential duty satisfactorily. Other duties may be assigned.
Assist or lead in the identification, investigation, and implementation of CAPA.
Assist or lead Control of Nonconforming Product process activities (e.g., MRB review/approval).
Facilitate the execution of Risk Management activities.
Support new product development and production (e.g., Change Control implementation activities).
Provides support necessary for supplier controls, including but not limited to, supplier audits when
Support validation activities for new and existing products, process and equipment and identify
statistically based sampling plans for inspections and validations.
Aid in the implementation SPC control system with Manufacturing and Quality Control.
Establish and maintain Quality Management System procedures related to areas of responsibilities.
Ensure compliance with cGMP, QSR, ISO13485, MDD/EU MDR, and other applicable regulations/
Participate in FDA inspections, ISO Certification and surveillance audits and customer audits.
Identify and implement opportunities for continuous improvement.
Collection and reporting of metrics and data as required.
Performs other Quality Management System related duties as required.
DESIRED MINIMUM QUALIFICATIONS
BS degree in Engineering, Math or Science (Biology, Chemistry, Physics, Statistics, etc.) or 3-3 years
of working experience in Quality Assurance/Control.
Minimum of two years’ experience in a regulated industry, preferably Medical Device Industry
Experience with CAPA processes (e.g., complaints, nonconforming product).
Exposure to medical device regulations (including FDA QSRs, ISO13485).
Technical aptitude (i.e. able to read and comprehend technical documentation, ability to comprehend
and execute procedures, demonstrated understanding of system documentation).
Knowledge of statistical sampling and analysis.
Ability to communicate effectively (both written and oral).
Familiar with the MS Office Suite, including Microsoft Visio and Project.
If you are interested, Kindly send your resume to firstname.lastname@example.org