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 aQuality Assurance Engineer I to join our team. The selected candidate will support internal audits and external inspections by assisting with planning, data collection, evidence verification, analysis, documentation, and follow-up activities. The engineer will coordinate with multidisciplinary teams to prepare required data and documentation and participate in front-room and back-room activities, as needed.

The engineer will also collect, analyze, and present Quality System performance data to senior management and support similar activities at other company sites. This role will collaborate with cross-functional and cross-site teams, complete assignments within established timelines, and escalate significant compliance concerns as appropriate.

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

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

• Participates in internal audits and supports customer inspections by assisting with planning, evidence collection, documentation, and audit reports.

• Supports the tracking, review, and closure of corrections and corrective actions under appropriate guidance.

• Supports activities resulting from internal audit findings and other QMSR, ISO, or Quality System requirements.

• Supports the collection, verification, and analysis of Quality System data for the local site and other company sites, as assigned.

• Supports the preparation and presentation of data for Management Review and other Quality System performance meetings.

• Reviews assigned Quality System performance information and assists in identifying and implementing improvement opportunities.

• Supports the management and maintenance of applicable external standards and related controlled documents.

• Escalates significant compliance concerns, identified gaps, and potential Quality System risks to senior personnel or management.

• Supports Quality System activities related to Training Management, CAPA, Complaint Management, and External Standards Management, 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.