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Quality Assurance Associate

3 weeks ago

Surrey, Canada HealthTech Connex Full time

Our business model is to **MEASURE**, **TEST**, and** TREAT** for optimal brain health. We accomplish this through our subsidiaries as follows:

- TREAT - Surrey Neuroplasticity Clinic: Our neurorehabilitation clinic focuses on comprehensive therapies using advanced, non-invasive brain technologies to help treat people with neurological conditions. (snpc.tech)

Our purpose is to **Boldly Elevate People.** Our core values are to be **GREAT** (**G**rowth Mindset, **R**espectful, **E**levates Others, **A**uthentic and has **T**rue Grit). Work with us to positively impact a billion brains

**Job Summary**

The Quality Assurance Associate will be responsible for working with a cross-functional team to ensure our product meets all the quality attributes of safety, efficacy, potency, and purity required by customers, regulatory agencies, and the company.

**Responsibilities**
- Ensuring that processes needed for the quality management system (QMS) are documented
- Reporting to the QA Lead on the effectiveness of the quality management system and any need for improvement
- Ensuring the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization
- Administering QMS, including SOP, training, and CAPAs
- Assisting with investigations of non-conformances, including root cause analysis
- Hosting client/sponsor audits and regulatory inspections
- Coordinating and conducting assessments of potential and contracted suppliers, including supplier audits
- Participate in internal and external audits of the QMS
- Developing and administering training for employees and consultants
- Participating in change control, corrective, and preventive action system, and nonconformance records
- Providing QA consultation and support to assigned project teams internally and externally and according to defined quality oversight plans as applicable
- Monitoring quality systems to provide feedback on compliance risks to QA management and find opportunities for improvement
- Creating, reviewing, and maintaining labeling material
- Reviewing and maintaining Device History Records
- Inspecting outgoing shipments, including review of testing documentation, visual inspection of products, and reviewing of shipping documentation
- Supporting all registration activities
- Assisting in maintaining the product complaint system for all products
- Assisting with coordinating any necessary recalls/withdrawals
- Responsible for Document Control and Quality Control systems
- Other duties as assigned

**Qualifications and Experience**
- Bachelor's degree (or equivalent) in an engineering, science, healthcare, or related field of study
- Two to five years of experience
- Experience with ISO 13485 and MDSAP
- Strong problem-solving skills, with sound judgment and the ability to make decisions independently in an environment that balances business needs, quality, and compliance risk

**The Finer Details**
- This is a full-time position
- You will be based in the HealthTech Connex head office located at 13761 96th Avenue, Surrey.
- We work in a hybrid work environment
- Proposed start date: As soon as possible

**What We Offer**
- The opportunity to work in a dynamic, innovative, and technology-driven environment with an engaging and supportive work culture. We strive to “Boldly Elevate People” and are dedicated to supporting internal growth as we take on new challenges in exciting, and forward-thinking industries. As we grow, you will too.
- We offer a competitive compensation package, including a generous base salary commensurate with experience, excellent extended health, and dental coverage, Registered Pension Plan (RPP) matching, paid parking for all on-site staff, flexible vacation, and employee stock options.
- Our head office comes with additional benefits Enjoy the rooftop terrace patio with stunning mountain views, access to 24/7 on-site gym facilities, weekly in-house fitness classes, healthy (and, sometimes, not-so-healthy) office snacks, and cupboards filled to the brim with coffee.

**Our Commitment to Equity, Diversity, and Inclusion**

**How to Apply