Quality Assurance Engineer, Staff

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, Staff to join our team in Costa Rica. The selected candidate will work on problem-solving and process improvement projects of moderate scope, applying analytical skills and engineering judgment to evaluate data, identify key factors, and develop effective solutions. Participate in defining project scope, selecting appropriate equipment, and establishing task timelines. Support the analysis and implementation of design changes to meet revised specifications during manufacturing.

Provide solutions to problems of limited scope and manages broad assignments with increasing independence. Provide technical guidance and knowledge sharing to peers within the work team. Develops, writes, and executes manufacturing validation protocols, test method validations, software validations, and other quality-related validation activities. Collaborate with cross-functional teams on manufacturing improvement and process transfer projects at the site level, as required.

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

• Apply and maintain quality standards for materials, products, and manufacturing processes.

• Implement inspection, testing, measurement, and acceptance methods to ensure product and process quality.

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

• Manage supplier quality activities, including evaluation of Supplier Corrective Action Responses (SCARs).

• Develop, execute, and approve process and test method validation protocols, reports, and strategies.

• Act as a validation assessor for manufacturing processes and support validation activities for sustaining and new processes.

• Lead quality activities related to product and process transfers, including Quality System migration/integration and validation strategy.

• Drive quality documentation and process changes, including acceptance criteria for manufacturing and transferred product lines.

• Support Risk Management activities, including PFMEA development and updates.

• Conduct internal audits and support external audits and customer/regulatory inquiries.

• Select and ensure appropriate equipment is available and compliant with quality, safety, and environmental requirements.

• Provide technical guidance and coordinate the work of technicians and other support personnel.

• Ensure proper segregation and disposition of nonconforming products in accordance with internal procedures.

• Ensure compliance with company quality, safety, regulatory, and environmental requirements.

• Collaborate with cross-functional teams to support continuous improvement and departmental and company goals.

• Perform other duties as assigned by the Quality Manager.

EDUCATION and/or EXPERIENCE:

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

• Minimum of 5 years of relevant experience across manufacturing processes, technologies, and Quality Systems, including areas such as Process Validation, Software Validation, Risk Management, Supplier Management, CAPA, Complaints, NCRs, Calibration, Audits, Document Control, Quality Control, Quality Metrics, and Change Control.

• Proficient oral and written English skills. (B2/C1)

• 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.

• Internal Auditor training or certification in ISO 13485 is an asset.

OTHER SKILLS and ABILITIES:

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

• Experience in process validation within the medical device industry is a strong asset.

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

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

• Ability to read, analyze, and interpret scientific and technical information and effectively communicate complex concepts to employees, customers, regulatory agencies, and other stakeholders.

• Strong mathematical and statistical skills, including data analysis, sampling theory, test reliability and validity, analysis of variance, and correlation techniques.

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

• Ability to interpret complex technical instructions, diagrams, and procedures and work effectively with both abstract and concrete variables.

• Proficient computer skills, including email, Microsoft Office, databases, spreadsheets, graphics, ERP systems, and electronic record-keeping.

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.