R&D Quality Assurance Engineer I-II

The R&D Quality Engineer I–II is a member of the Quality organization supporting the design, development, and commercialization of medical devices within Aptyx. This role partners closely with R&D, Manufacturing, Regulatory, and Operations to ensure compliance with the Aptyx Quality Management System (QMS) and applicable regulatory requirements throughout the product lifecycle.

The position supports development programs from concept through production for disposable medical devices including catheters, catheter-based delivery systems, and other single-use devices across multiple therapeutic areas such as cardiology, neurology, and urology.

This role is intended to grow from an entry-to-developing engineer (Level I) into a fully independent contributor and project-level quality leader (Level II), with increasing responsibility for design control leadership, problem solving, and cross-functional influence.

Duties and Responsibilities

Quality System & Regulatory Compliance

• Follow and apply the Aptyx Quality Management System (QMS), including applicable SOPs and work instructions
• Ensure compliance with ISO 13485, FDA QSR, and applicable internal and customer requirements
• Support audit readiness and participate in internal and external audits as needed
• Identify and recommend improvements to quality system processes

Design Controls & DHF Support

• Support and/or review Design History File (DHF) documentation including:
  • User needs and design inputs
  • Engineering specifications and design outputs
  • Verification and validation protocols and reports
  • Drawings, material specifications, and design plans
• Ensure design control deliverables are complete, traceable, and compliant
• (Level II) Act as quality representative on development teams and influence design decisions to ensure compliance and quality-by-design principles

Risk Management

• Support risk management activities in accordance with ISO 14971
• Participate in FMEAs and risk assessments for design and process development
• (Level II) Review and help drive linkage between risk management, verification testing, and design controls

Testing, Verification & Validation Support

• Assist in development, review, and execution of test protocols and reports
• Support design verification, validation, and process validation activities
• Support sampling plans and basic statistical analysis of test data
• (Level II) Apply statistical tools to evaluate test results, support Gage R&R, and improve test method robustness

Inspection, Metrology & Manufacturing Support

• Support inspection activities and quality control processes for R&D builds and production transfer
• Assist in use of measurement systems and inspection equipment (e.g., vision systems, CMM, gauges)
• Support resolution of nonconforming material and build issues
• (Level II) Provide technical guidance on inspection methods, metrology systems, and inspector training

Nonconformance, CAPA & Problem Solving

• Support investigation and documentation of nonconforming materials (NCRs)
• Participate in CAPA investigations and root cause analysis activities
• (Level II) Lead or champion NCR and CAPA activities, ensuring timely closure and effective corrective actions
• Apply structured problem-solving tools to support issue resolution

Supplier Quality Support

• Support communication with suppliers regarding quality issues and material disposition
• Assist with incoming inspection criteria and supplier quality documentation
• (Level II) Help drive supplier corrective actions and continuous improvement initiatives

Documentation & Quality Records

• Support preparation, review, and maintenance of quality records including:
  • DHF documentation
  • Inspection records
  • Test reports
  • Lot history records
• Ensure compliance with Good Documentation Practices (GDP)
• (Level II) Perform detailed review and approval of quality records and technical documentation

Customer & Cross-Functional Support

• Participate in cross-functional team meetings and provide input on quality-related topics
• Support customer interactions related to quality and development activities
• (Level II) Represent Aptyx in customer meetings and influence cross-functional teams toward a "quality-first" mindset

Training & Development

• Support training of inspection and manufacturing personnel on quality requirements
• (Level II) Develop and deliver training for inspectors and engineers on quality system expectations and R&D requirements
• Support knowledge sharing and consistency of quality interpretation across teams

Sterilization & Audit Support

• Support sterilization documentation and validation activities as needed
• Participate in internal and external audits of quality systems and development programs
• (Level II) May serve as lead auditee for assigned areas

Qualifications

Education

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Materials Science, Physics, or related field

Experience

• Level I: 1–3 years of experience in Quality Engineering or related engineering role in a regulated environment
• Level II: 3–5 years of experience in Quality Engineering or medical device development preferred
• Medical device industry experience preferred
• ISO 13485 and FDA regulated environment experience preferred

Skills, Knowledge & Abilities

Core Technical Skills

• Understanding of ISO 13485 Quality Management Systems
• Knowledge of ISO 14971 Risk Management principles
• Familiarity with FDA QSR (21 CFR Part 820) requirements
• Experience with medical device testing, protocols, and report writing
• Basic statistical knowledge (SPC, sampling plans)
• (Level II) Advanced statistical analysis (e.g., Minitab, Gage R&R, DOE exposure preferred)

Problem Solving & Execution

• Strong analytical and structured problem-solving skills
• Ability to support root cause investigations and corrective actions
• Ability to manage multiple priorities and deliverables
• (Level II) Ability to lead problem-solving activities and drive closure of quality issues

Communication & Influence

• Strong written and verbal communication skills
• Ability to work effectively in cross-functional teams
• Strong attention to detail and documentation discipline
• (Level II) Ability to influence engineering and operations teams without direct authority

Tools & Systems (Preferred)

• Microsoft Office (required)
• CAD exposure (preferred)
• Minitab or similar statistical tools (preferred for Level II)
• Familiarity with QMS systems and document control systems

Progression Expectations

Level I – Developing Engineer

• Executes assigned quality tasks with supervision
• Supports DHF, testing, and inspection activities
• Participates in CAPA/NCR investigations
• Builds foundational knowledge of design controls and ISO/FDA requirements

Level II – Independent / Project-Level Engineer

• Independently leads quality workstreams within development projects
• Acts as quality representative on cross-functional teams
• Leads NCR/CAPA activities and drives resolution
• Influences design decisions and promotes quality-by-design thinking
• Trains and mentors junior engineers and inspection staff
• Provides higher-level technical input into risk, validation, and test strategy

Measurement of Performance

1. Timely and accurate execution of assigned quality and R&D deliverables
2. Quality and completeness of DHF, CAPA, NCR, and validation documentation
3. Effectiveness in identifying and resolving quality issues
4. Compliance with ISO 13485, FDA, and internal quality system requirements
5. Collaboration and influence across R&D, Manufacturing, and Supplier teams
6. Demonstrated progression in independence, technical depth, and leadership (Level I → II)
7. Contribution to audit readiness and successful audit outcomes

Acknowledgement