Talent.com
fluidigm
QA/RA Associatefluidigm • Markham, ON, CA
QA/RA Associate

QA/RA Associate

fluidigm • Markham, ON, CA
30+ days ago
Salary
CA$55,000.00 yearly
Job type
  • Full-time
Job description

QA/RA Associate

Job Locations CA-ON-Markham Req No. 2023-3769 Category Quality Assurance / Regulatory Type Regular

Job Description

It is an extraordinary time for Standard BioTools. Our technology is empowering customers to improve life through comprehensive health insight. We invite you to join a leading provider of indispensable life sciences tools that is accelerating global research on multiple frontiers of human health.

At Standard BioTools, we are building a positive culture where our people can do the best work of their careers, informed, and influenced by our core behaviors:

  • Keep customers front and center in all of our work
  • Be accountable and deliver on commitments
  • Drive continuous improvement
  • Be collaborative and work as one team: fostering communications in a learning, coaching, and helpful environment

Standard BioTools is looking for a Quality Assurance/Regulatory Affairs Associate to support the products’ quality and regulatory activities. The Quality Assurance and Regulatory Affairs associate is responsible for maintaining and ensuring that the company quality system meets requirements for medical devices, and International Directives. The QA/RA Associate is also responsible for ensuring that products and their labeling meet all regulatory requirements (national and international) such as REACH, RoHS, WEEE, CE, etc.

Description

  • Maintain Technical Documentation files in compliance with international requirements.
  • Oversee the company REACH and Safety Data Sheet program.
  • Approval and release of Quality Records, Device History Records, Batch Records Master Labels and Device Master Records.
  • Support and administration of risk assessment review process and implementation of changes to risk management process as needed.
  • Liaison with domestic and international customers and vendors to ensure compliance with standards and execution of corrective actions.
  • Development of controlled documents and procedures pertinent to Quality Assurance activities and functions.
  • Assists with customer complaints/CAPA system.
  • Supports new product development, risk analysis, and launch processes, and manage QA participation on new production development.

Minimum Qualifications:

  • Bachelor’s degree required, life science / engineering.
  • Regulatory Affairs / Quality Management RAC certificate is preferred.
  • Experience with ISO 13485, ISO 9001, required.
  • Knowledge of and experience with the following standards: IEC 60601-1, ISO 13485, ISO 14971, IEC 62366, IEC 62304, CE-IVDR and 21 CFR 820.
  • Knowledge with REACH, RoHS, WEEE, CE mark, UKCA directives and Safety Data Sheet compliance.
  • ASQ Certification preferred but not required (such as CQA, CQE, CMQ/OE).
  • 1-2 years of industry experience preferred.
  • ISO 13485 Internal Auditor certificate a plus.
  • Salesforce Experience a plus.
  • Basic knowledge of Excel.
  • Fast learner, self-starter, accountable, reliable.
  • Ability to successfully work in a dynamic environment.
  • Able to work under pressure and tight timelines.
  • Problem solving attitude.
  • Cross-functional perspective and coordination.

The Company is committed to providing an inclusive and barrier free recruitment process to applicants with accessibility needs in accordance with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act (AODA). If you require an accommodation during this process, please inform The Company of your requirements. We are an equal opportunity employer.

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later. Share on your newsfeed
Socialize this job opportunity to a friend, colleague, or family member:

Software Powered by iCIMS

Create a job alert for this search

QA/RA Associate • Markham, ON, CA

Similar jobs

Senior QA Analyst — Fixed Income UAT & Automation

CanDealToronto, ON, CA
Full-time

A leading financial data services provider in Toronto is seeking a QA Analyst to join their IT team.This role focuses on User Acceptance Testing (UAT) and involves developing test plans, executing ... Show more

 • Promoted

Sr. Clinical Research Associate-Sponsor Dedicated

ICON Strategic SolutionsGreater Toronto Area, Canada, Canada
Full-time

CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.Ensuring regulatory, ICH-GCP and protocol compliance.Uses judgmen... Show more

 • Promoted

Remote QA Analyst – FDA‑Regulated Trials

Clario Holdings Inc.Toronto, ON, CA
Remote
Full-time

A leading data solutions provider for clinical trials is seeking a Quality Analyst to oversee quality metrics and process improvements.The role requires a Bachelor's degree in a scientific field an... Show more

 • Promoted

Sr. QA Manual Testing - Canada (Remote)

RELQ TECHNOLOGIESToronto, ON, CA
Remote
Full-time

Client Domain – Product-based company - HRMS (Human Resource Management System) applications focused on SaaS-based HRMS solutions for the public sector.The ideal candidate has experience working in... Show more

 • Promoted

Quality Assurance Associate

Arrow Workforce Solutionstoronto, on, ca
Full-time

Position: Quality Assurance (QA) Associate.Full Time, Contract (6 months).We are currently hiring a QA Associate to support food safety and quality assurance across both kitchen and meat production... Show more

 • Promoted

QA Coordinator

New School Foods (powered by NS/TX)Toronto, ON, CA
Full-time

At New School Foods, our mission is to accelerate the transition to a kinder, healthier, alt‑protein‑first food system.Using our proprietary production technology, we create zero‑compromise meat al... Show more

 • Promoted

QA Specialist III — Elevate Product Quality

Maplesoft Group, an SEB CompanyToronto, ON, CA
Full-time

A leading technology consulting firm is looking for a remote Quality Assurance Specialist/Analyst to support their Network Modernization initiatives.Candidates should possess a minimum of 10 years ... Show more

 • Promoted

Control Tester Senior Associate Role

Capital One CanadaToronto, ON, CA
Full-time

Join Capital One Canada as a Senior Associate for Control Testing, focusing on critical risk management initiatives in a hybrid environment.Leverage your expertise in compliance and analytical skil... Show more

 • Promoted

QA Lead for Testing Strategies

Symbiotic GroupToronto, ON, CA
Full-time

Shape quality assurance efforts as a QA Lead.Manage testing strategies, execute comprehensive test cases, and ensure high-caliber solutions through robust defect management.You will contribute to d... Show more

 • Promoted

PV/QC Associate - Q&R Canada Inc.

Q&R Canada Inc.toronto, on, ca
Full-time

PV/Quality Assurance Associate to join their team of high performers to manage the regulatory and post-market compliance activities of their partners for the Canadian region.Perform literature sear... Show more

 • Promoted

Research Quality Associate

University Health NetworkToronto, ON, CA
Full-time

UHN is Canada’s #1 hospital and the world’s #1 publicly funded hospital.With 10 sites including Toronto General Hospital, Toronto Western Hospital, Princess Margaret Cancer Centre, Toronto Rehabili... Show more

 • Promoted

Lead QA Analyst

CI Financial Corp.Toronto, ON, CA
Full-time

At CI, we see a great place to work as one that is a safe place for everyone to have a voice, where people are empowered to take ownership over meaningful work, where there is an opportunity to gro... Show more

 • Promoted

Piramal Pharma Senior QA Associate Role

Piramal Pharma LimitedAurora, York Region, CA
Full-time

Join Piramal Pharma Solutions in Aurora, CA, as a Senior QA Associate.Ensure strict CGMP adherence and engage in continual quality enhancements in our operations.In your role as Senior QA Associate... Show more

 • Promoted

Quality Assurance Associate

Emerald Lane RecruitmentMarkham, York Region, CA
Full-time

Quality Assurance & Inventory Control Associate.Our client is a licensed producer (LP) focused on the manufacturing and processing of medical cannabis products.Quality Assurance & Inventory Control... Show more

 • Promoted

Quality Control Associate I in Cutting-Edge Medical Innovations

CCRMToronto, ON, CA
Full-time

Launch your career as a Quality Control Associate I in the revolutionary field of cell and gene therapy.Utilize your skills to support crucial quality control initiatives that bring innovative trea... Show more

 • Promoted

Quality Operations Associate Director Role

Apotex Inc.Richmond Hill, York Region, CA
Full-time

Join Apotex as the Associate Director of Quality Operations, where you will enhance the manufacturing site’s quality excellence in Richmond Hill.Your impactful leadership in regulatory compliance w... Show more

 • Promoted

GVP QA Lead — R&D Audit & PV Compliance

Mundipharma InternationalToronto, ON, CA
Full-time

A global healthcare company is seeking an experienced R&D QA Manager to join their Quality Assurance team in Toronto.The role involves overseeing quality compliance in pharmacovigilance and managin... Show more

 • Promoted

AML QA Associate Manager Hybrid Lead Compliance Contract

EQ Bank | Equitable BankToronto, ON, CA
Full-time

A leading financial institution in Toronto is seeking an Associate Manager, AML Quality Assurance to oversee compliance with AML/ATF regulations.This role involves developing quality assurance proc... Show more

 • Promoted

Associate Director - Regulatory Capital, Data & Business Solutions

ODAIAToronto, ON, CA
Full-time

In this exciting position, you’ll have the chance to work as a Product Owner delegate & SME, to develop design, solutions, and data driven requirements on all key projects, enhancements, upgrades, ... Show more

 • Promoted

Associate Director, Quality Operations

ApotexRichmond Hill, York Region, CA
Full-time

Apotex is a Canadian-based global health company.We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of gener... Show more