QMS Quality Assurance Specialist - Medical Devices (Vancouver)

SaNOtize Research and Development Corp.; Vancouver; On-site; CAD 60,000 - 80,000; Full time

Job summary

An innovative biotech company is seeking a Quality Assurance Specialist to maintain and improve its Quality Management System. The successful candidate will have a bachelor's degree and 3-5 years of relevant experience, focusing on regulatory compliance and quality standards in product development and manufacturing. This full-time position offers a collaborative environment with competitive salary and benefits package.

Benefits

3 weeks of vacation time per year

Annual bonus opportunity

Competitive health and dental plan

Health spending account

Stock options

Qualifications

• 3-5 years of hands-on experience in a Quality role within the cosmetics, personal care, medical device or pharmaceutical industries.
• Knowledge of GMP, FDA, and relevant regulations and standards.
• Experience with laboratory testing methods (microbiological, chemical, stability testing).

Responsibilities

• Maintain and improve QMS documentation and records.
• Participate in product development activities including design reviews.
• Collaborate with production teams to implement quality assurance strategies.

Skills

Detail-oriented

Excellent organizational skills

Strong analytical skills

Communication skills

Education

Bachelor’s degree in engineering, life sciences, or related field

Tools

Microsoft Office Suite

Quality management systems

Job description

SaNOtize is an innovative biotech company, developing novel topical products based upon our proprietary Nitric Oxide release technology, shown to inactivate viruses, bacteria and fungi. Based in Vancouver, Canada, we are leveraging this technology to create novel wellness products for launch into both ecommerce and a direct sales channel to physicians in the US, under the NOWONDER brand. Being a leader in nitric oxide delivery requires a team of dedicated experts, from scientists to businesspeople and more. The ‘small but mighty’ SaNOtize team is united in our commitment to challenge traditional thinking around antimicrobials—and growing fast! Join us!

Position Overview

We are seeking a detail-oriented and highly organized Quality Assurance Specialist to support our Quality Assurance team with the maintenance and continuous improvement of our Quality Management System (QMS) and ensuring that our products and processes meet regulatory and quality standards from design and development through production and post-market.

Core Responsibilities

QMS :

• Maintain and improve QMS documentation and records.
• Provide quality input during change evaluations to ensure continuous quality and regulatory compliance. Ensure accurate training records are maintained.

Design & Development Support :

Participate in product development activities, including design reviews and verification / validation processes.

Ensure accurate documentation of design inputs, outputs, and traceability.

Manufacturing & Process Support :

Collaborate with production teams to implement quality assurance strategies in manufacturing to ensure products meet both internal and external quality and regulatory standards, including safety and performance.

Support process validation (IQ / OQ / PQ), batch record reviews and ongoing process monitoring, and ensure quality controls are effective.

CAPA & Nonconformance (NC) :

Support root cause analysis and investigations into product and process NC and deviations.

Monitor implementation and effectiveness of corrective and preventive actions (CAPAs).

Supplier Quality Monitoring :

Participate in supplier qualification, monitoring, and performance evaluation.

Review incoming inspection records and address supplier-related nonconformances to ensure that materials and services meet specifications.

Regulatory Compliance and Audits :

Stay up to date on evolving regulations. Monitor and ensure company adherence to industry-specific regulations, including FDA, ISO, GMP, and other global standards.

Participate in internal and external audits and inspections to ensure quality management system compliance and identify areas for improvement.

Customer Feedback and Continuous Improvement :

Support complaint handling and adverse event reporting processes.

Assist with trend analysis and feedback into the risk management and CAPA systems.

Product Testing and Analysis :

Conduct stability testing, microbiological testing, and efficacy testing on product formulations as required.

Additional Responsibilities :

Participate in training and self-learning activities to grow knowledge in regulatory requirements and quality systems improvement.

Use knowledge to support and work closely with other departments or projects as needed, depending on the organization's needs.

This job description is not exhaustive and may be subject to change or revision at the company's discretion to reflect changes in the business environment or other organizational needs.

Required Qualifications :

Bachelor’s degree in engineering, life sciences, or related field.

3-5 years of hands-on experience in a Quality role within the cosmetics, personal care, medical device or pharmaceutical industries.

Knowledge of GMP, FDA, and relevant regulations and standards.

Strong understanding of quality assurance activities such as document control, supplier quality, CAPA and non-conformity investigations, risk management or design controls.

Experience with laboratory testing methods (microbiological, chemical, stability testing).

Proven ability to work effectively within cross-functional and diverse teams, thriving in a collaborative and innovative setting.

Detail-oriented with excellent organizational, documentation, analytical, and communication skills.

Proficient in Microsoft Office Suite, and comfortable using quality management systems.

Preferred Qualifications :

Experience with product development, formulation, or manufacturing activities.

Familiarity with electronic QMS or document control systems

Enthusiasm for quality processes and continuous improvement.

Salary : $60,000 to $80,000 per year, commensurate with experience.

Benefits : 3 weeks of vacation time / year, annual bonus opportunity, competitive extended health and dental plan for employees’ and family coverage on their first day, health spending account and stock options.

Seniority level

Seniority level

Mid-Senior level

Employment type

Employment type

Full-time

Job function

Job function

Quality Assurance

Referrals increase your chances of interviewing at SaNOtize Research and Development Corp. by 2x

Get notified about new Quality Assurance Specialist jobs in Greater Vancouver Metropolitan Area .

Burnaby, British Columbia, Canada 1 week ago

Port Coquitlam, British Columbia, Canada 1 week ago

Burnaby, British Columbia, Canada 3 weeks ago

Burnaby, British Columbia, Canada 6 months ago

Delta, British Columbia, Canada CA$57,000.00-CA$75,000.00 6 days ago

Surrey, British Columbia, Canada 1 month ago

Burnaby, British Columbia, Canada 5 months ago

Software Quality Assurance Analyst - FTT

Burnaby, British Columbia, Canada 3 days ago

Freelance Mathematics Expert - Quality Assurance (AI Trainer)

Senior Release QA Specialist (Network / WiFi)

Burnaby, British Columbia, Canada 2 months ago

Freelance Physics Expert - Quality Assurance (AI Trainer)

Burnaby, British Columbia, Canada 3 months ago

Machine Learning Quality Assurance Engineer

CAN) Distribution Centre Team Associate - Quality Assurance Contract September - June Wed- Sun 12 AM - 8 : 30AM

Surrey, British Columbia, Canada 11 hours ago

Food Safety & Quality Assurance Analyst (Central Kitchen)

Richmond, British Columbia, Canada 2 months ago

Burnaby, British Columbia, Canada 1 week ago

Product Engineer, Electrical Engineering

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

J-18808-Ljbffr