Quality Operation Specialist (CAPA)

Why join our team?

Think you have what it takes to work in an organization where creativity and ambition are valued and integrity drives everything we do?

Medicom has been in business for over 35 years, and it has kept its entrepreneurial mindset. Working with us, you will have the opportunity to get involved, have an impact, and contribute to the company’s continued growth.

We live by our values every day, focussing on customer satisfaction while ensuring teamwork, accountability, and empathy in everything we do.

Our team loves challenges and a fast-paced environment. You will have the flexibility to manage work and a personal life, as well as your own personal well-being.

We offer an attractive compensation package with benefits.

The Opportunity

As Quality Operations Specialist, you will perform live audits, provide training, and support QA activities.

What you will do

• Perform on the floor live audits of the manufacturing facility, warehouse and QC laboratory;
• Provide training on quality processes and / or revised procedures., etc.;
• Manage and track Stinson change requests;
• Manage, coordinate and support operational continuous improvement efforts;
• Participate in the drafting and review of Standard Operating Procedures;
• Support KPI data collection and analysis;
• Assist and support investigations, capas, capa effectiveness and NCMR process;
• Support the processing of SCARS; Review validation protocols and reports for completeness and accuracy (as required);
• Perform data entry tasks, as necessary, on various tracking tools within the Quality System;
• Support QA activities, such as archiving, batch release, raw material release, live on the floor QA oversight of production activities and coordinate sample shipment as necessary, for external testing;
• Other related duties / responsibilities as required or assigned by the Manager.

What you will bring

• A minimum of 3 years of experience in a GMP (Good Manufacturing Practices) environment, in the pharmaceutical or medical devices industry, or closely related field;
• A minimum of 2 years of experience in a quality role;
• DEC in a related field;
• Detail and solution oriented;
• Good written and verbal communication skills in both English and French;
• Ability to make sound quality decisions;
• Ability to work in a dynamic environment with multiple priorities and meet deadlines;
• Ability to demonstrate the Medicom core values of Teamwork, Accountability and Customer Centricity.

The following would be an asset

• Knowledge of ISO 13485 and 21CFR820 requirements;
• Certificate in Quality Assurance or knowledge of Root Cause Analysis methodology;
• Technical knowledge of similar types of medical devices. What we offer
• Competitive salary;
• Comprehensive insurance program including EAP and telemedicine for you and your family;
• Pension plan with company matching;
• Possibility of a hybrid work schedule, with home internet and office expense allowance;
• Yearly stipend for professional development;
• Fun work atmosphere, an active social committee that organizes fun activities such as sports, BBQs, family events and more!

Equal Opportunity Employer

Medicom is an equal opportunity employer. We consider all applicants without regard to age, gender, gender identity or expression, sexual orientation, race, ethnic or national origin, religious beliefs, sex (including pregnancy and breastfeeding), disability or marital or family status.

We welcome applications from all qualified individuals and encourage Indigenous persons, persons of color, LGBTQ+ and gender-nonconforming persons, persons with disabilities, women, and members of any other marginalized group.

If you are energetic, committed to making a difference and love challenges, we would love to hear from you. Visit our website at https : / / medicom.

com / careers / and apply today!