Quality Assurance Associate
Microdermics is a Vancouver based company aiming to revolutionize the current drug delivery methods by commercializing novel and innovative intradermal injection platform.
If you are an enthusiastic Quality Assurance (QA) Associate with 2+ years of experience in medical devices or pharmaceuticals QA, and able to work within cross-functional teams, we need you to help establish the quality system and drive compliance to ISO 13485 Quality Management System and FDA Requirements.
In this position, you will apply your QA knowledge to ensure that procedures, specifications, and manufacturing process controls are appropriately documented and followed. You must be able to work effectively in a fast-paced and dynamic environment, and quickly adapt to new challenges. In addition, you will be working and interacting with the entire community of ventures in the Hatch Incubator and Creative Destruction Labs ecosystems to build a massive and impactful business.
Vancouver, BC Canada
You will also be responsible for
- Establish and implement quality systems compliant with ISO 13485 and FDA QSR
- Audit for compliance to policies and procedures and report on the performance of the quality system
- Conduct QA review of process validation, documentation and SOPs
- Specify quality requirements of materials and parts with suppliers
- Document product development process
- Maintain and update protocols, procedures, processes, solutions and results reports related to implementation and monitoring of quality assurance measures
Required Skills and Qualifications
- 2+ years in medical devices [ISO 13485 and FDA QSR] or Pharma QA is required
- Ability to wear multiple hats, multitask, and manage competing priorities
- Excellent time management and priority setting skills
- Ability to work independently as well as a team player with well-developed interpersonal skills, who is comfortable in a cross-functional multi-cultural environment
- Ability to exercise sound judgment and communicate clearly to follow through tasks to be completed
If you are interested in this position, please send your cover letter and resume in one PDF document to email@example.com
Mar 31, 2018 or upon filing of the position