Tech 1, Quality Assurance

Job Description:
This position supports production at a medical device manufacturer. This requires entering in a controlled environment with appropriate gowning and PPE (e.g., hair net, beard cover (if applicable), safety glasses, safety shoes, hearing protection, smock). This position requires a lot of walking and standing on feet. This role requires the ability to detect visual defects such as surface irregularities, colour variations, and dimensional inconsistencies, with or without reasonable accommodation.
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Skillset Matrix



Manager Notes


Technology Requirements (I.E Programs, systems, etc)


Basic computer skills. Outlook, Microsoft Word, Excel,


Preferred: SAP


What does a typical day look like? (daily tasks)


typical day is focused on supporting production and maintaining product quality. They spend much of their time responding to nonconformances on the line, helping production understand the issue, and guiding them through the appropriate actions. When a defect is found, the Quality Tech assists with containment to make sure the affected product is isolated and controlled.


They also guide the documentation that comes with these events, such as assigning nonconformance tracking numbers and guiding how the details of what happened is recorded. Throughout the day, they perform spot checks on the production floor to verify that procedures are being followed correctly.


nother important part of the role is ensuring the production area remains GMP compliant. This includes checking cleanliness, organization, labeling, and general adherence to good manufacturing practices.


Preferred background/prior work experience?


Preferred previous quality assurance experience in the medical device or pharmaceutical industry


Priority soft skills


Good communication skills


Detailed oriented



Responsibilities:

• Provide training and feedback to operations staff to support skill development and compliance with quality standards.
• Promote a culture of quality, safety, and continuous improvement within the team.
• Monitor inspection processes and ensure adherence to SOPs, work instructions, and quality standards.
• Conduct daily audits of production areas and documentation to ensure compliance and identify improvement opportunities.
• Maintain accurate and timely documentation of inspections, audits, and quality events.
• Support preparation for internal and external audits.
• Identify and recommend improvements to inspection methods, tools, and documentation practices.
• ssist departments in containment and segregation of nonconforming product/materials and ensure proper documentation and escalation.
• Confirm defects of nonconforming product/materials found in production.
• ssist in root cause investigations and corrective action implementation for deviations and nonconformances.
• Collaborate with operations and engineering to resolve quality issues and improve inspection processes.
• Communicate effectively with cross-functional teams to support production goals and quality initiatives.
• Participate in quality improvement projects.
• Ensure compliance with all applicable safety regulations, including RCRA hazardous waste handling, and company policies.
• Perform other duties as assigned.

Work Environment:

• This position includes frequent work in a cleanroom or laboratory manufacturing environment and the physical demands described are representative of those that must be met by an incumbent to successfully perform the essential functions of this job.
• This position also includes frequent work in an office environment which requires use of a computer and its accessories.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions (Per the Americans with Disabilities Act of 1990).
• The incumbent may be frequently required to stand and/or occasionally sit for extended periods of time. Bending, stooping and reaching are also frequently required. While performing this job, the employee is regularly exposed to episodes of walking, kneeling, balancing, crouching, pushing/pulling, repetitive grasping, hearing, twisting, lifting, frequent use of hand to finger, handle, feel, pick or type which can include repetitive motion of the wrists, hands or fingers.
• The position will almost always have exposure to work near moving mechanical equipment, and potential temperature fluctuations.
• Occasionally the position will have exposure to fumes, airborne particles, hazardous chemicals, cleaning compounds and solvents.
• The incumbent may be exposed to noise levels in the work environment moderate to loud.
• The incumbent must be willing and able to wear the required PPE such as safety glasses, face mask and/or shield, hearing protection, safety shoes, smock, hairnet, and beard covering.