Quality Assurance Engineer II

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 seeking a Quality Assurance Engineer II o join our team in Costa Rica. The selected candidate will be work independently on problems and projects of moderate scope, applying sound engineering judgment and analyzing relevant data and identifiable factors to develop effective solutions. Participate in defining project scope, selecting appropriate equipment and resources, and establishing timelines. Evaluate and implement design changes to meet revised specifications and quality requirements. Develop practical solutions to problems of limited scope while effectively managing broader assignments. May provide technical guidance and support to less experienced engineering personnel.

Shift available: Mixed M-S (M - F 3:30pm - 10pm and Saturdays 7am - 3pm)

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.

• Design and implement inspection, testing, and measurement methods to ensure product and equipment quality and reliability.

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

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

• Prepare and maintain quality documentation, inspection procedures, validation protocols, and reports.

• Plan and execute engineering activities of moderate scope, applying independent judgment to evaluate and resolve quality and process issues.

• Support and lead quality activities related to product and process transfers, including Quality System migration/integration and validation strategies.

• Conduct or support internal, supplier, and external audits, including audit preparation and war room activities.

• Support responses to customers, regulatory agencies, suppliers, and other stakeholders regarding quality-related issues.

• Provide technical guidance and coordinate the work of technicians, inspectors, and other personnel supporting quality activities.

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

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

• Contribute to departmental and company goals while promoting a culture of quality, safety, and continuous improvement.

• Perform other duties as assigned.

EDUCATION and/or EXPERIENCE:

• Bachelor’s degree in Engineering or a related discipline (completed).

• Minimum of 2 years of relevant professional experience.

• Proficient oral and written English skills (B2 level).

• Strong knowledge of statistics and proficiency in Minitab (required).

• Experience in the medical device industry is preferred.

• Relevant professional certification and/or license is an asset.

• 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:

• Strong knowledge of quality engineering principles, practices, and standards, with experience in process validation within the medical device industry considered a significant asset.

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

• Ability to analyze and interpret technical documents, data, diagrams, and instructions, identify problems, establish facts, and develop sound conclusions and solutions.

• Strong written and verbal communication skills, with the ability to effectively communicate technical information to employees, customers, regulatory agencies, and other stakeholders.

• Ability to provide technical leadership through knowledge sharing, collaboration, and leading by example.

• Proficient computer skills, including email, Microsoft Office, spreadsheets, databases, record keeping, and other standard business applications.

• Ability to maintain confidentiality and handle sensitive information appropriately.

• Commitment to company safety, quality, and compliance policies and procedures, as well as participation in continuous improvement and team initiatives.

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.