Quality Assurance Engineer I

Job Description:

Confluent Medical Technologies is a financially healthy and rapidly growing medical device company dedicated to working collaboratively with our customers, taking their projects from rapid prototype into high volume production. Our unparalleled technical expertise, proven experience and partnership with our clients has allowed us to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering, and manufacturing. Our primary capabilities include: Nitinol components and tubing, balloon expandable stents and catheters, complex catheters, biomedical textiles, and high precision polymer tubing. We take pride in our position as the leader in the medical technology space and are driven by a passion to create products that our clients have envisioned for their customers.

We are looking for a Quality Assurance Engineer I to join our team. The selected candidate will work on problems and projects of moderate scope, applying analytical skills and engineering judgment to evaluate data, identify key factors, and develop effective solutions.

This role will participate in defining project scope, selecting appropriate equipment and resources, and establishing task timelines. The engineer will evaluate and implement design changes to meet revised specifications and quality requirements, while independently managing assignments and contributing to broader projects.

Shift available: M-F (8am - 5pm)

ESSENTIAL DUTIES AND RESPONSABILITIES include the following. Other duties may be assigned.

• Develop, implement, revise, and maintain quality standards for materials, products, and manufacturing processes.

• Support the design and implementation of inspection, testing, and measurement methods to ensure product and equipment quality.

• Analyze quality data, customer complaints, returned products, and nonconformances; support root cause investigations and corrective actions.

• Support supplier quality activities, including reviewing Supplier Corrective Action Responses (SCARs) and determining when supplier corrective actions are required.

• Prepare and maintain documentation for inspection, testing, validation, and quality procedures.

• Execute engineering activities of small scope, applying engineering judgment to evaluate and resolve quality and process issues.

• Support product and process transfers, including Quality System migration/integration and validation activities.

• Support internal, supplier, and external audits, as well as war room activities.

• Respond to quality-related inquiries from customers, suppliers, regulatory agencies, and other stakeholders.

• Coordinate the activities of technicians and other personnel supporting specific assignments.

• Participate in design reviews and pre-validation assessments to ensure new processes meet quality, safety, and environmental requirements.

• Ensure compliance with company, regulatory, Health, Safety & Environmental (HSE), and quality requirements.

• Contribute to continuous improvement and departmental and company goals.

• Perform other duties as assigned.

EDUCATION and/or EXPERIENCE:

• Bachelor’s degree in Engineering or a related discipline (completed).
• Minimum of 6 months of relevant professional experience
• Medium oral and written English level. (B1)
• Experience in the medical device industry is preferred.
• Certified Quality Engineer (CQE) certification is an asset.
• Training or certification as an Internal Auditor in ISO 9001, ISO 13485, or a biomedical-related field is an asset.

OTHER SKILLS and ABILITIES:  

• Knowledge of quality engineering principles, practices, and related technical disciplines.

• Experience or knowledge of process validation in the medical device industry is a strong asset.

• Knowledge of statistics and Minitab is preferred.

• Strong analytical, problem-solving, documentation, project management, multitasking, and customer service skills, with a strong focus on quality.

• Ability to read, analyze, and interpret technical documents, procedures, data, diagrams, and engineering instructions.

• Ability to define problems, collect and analyze data, establish facts, draw sound conclusions, and develop effective solutions.

• Strong written and verbal communication skills, with the ability to effectively present technical information to internal teams.

• Proficient computer skills, including email, Microsoft Office, spreadsheets, databases, documentation, and record keeping.

• Ability to maintain confidentiality and handle sensitive information appropriately.

ENVIRONMENTAL WORKING CONDITIONS

Well-lighted, heated and/or air-conditioned indoor office setting with adequate ventilation.

PHYSICAL DEMANDS

Other physical working conditions:     

Lifting or carrying items.

Moderate noise (examples: business office with computers and printers, light traffic)

PHYSICAL ACTIVITY LEVEL: Moderate physical activity moving around the manufacturing process and offices areas, as well as performing somewhat strenuous daily activities of a primarily administrative nature.

This position description is an outline of the major recurring responsibilities of the job. It is not intended to be all-inclusive of the work to be performed. The incumbent(s) will typically perform other related job objectives, special assignments and less significant responsibilities.