Design Assurance Specialist

Job Description

The product quality engineer shares a passion for ensuring the highest quality experiences for our patients and customers. This position will be responsible for driving and supporting the quality engineering activities pertaining to lifecycle management including design control, product & process validation and risk management for the relevant product platforms.

The daily tasks will for instance include driving product quality investigations resulting from complaints as well as supporting/driving root cause investigations concerning product and manufacturing issues. This entails reviewing and aligning CAPAs (corrective action / preventive action) according to corporate procedures and guidelines across the division. Other tasks constitute understanding complex processes, problems and quality/compliance issues and describing these in a ‘to the point’ manor that will ensure readability in audit and inspections settings.

This will be done in close collaboration with other quality functions across the company and the post market surveillance specialists, who are also part of the team.

It is also expected that the position supports R&D in ensuring compliance when making minor design changes and updates to our product portfolio.

Under limited supervision/general direction and in accordance with all applicable federal, state and local laws/regulations and corporate procedures and guidelines, this position:

• Applies advanced Quality Engineering/Scientific Method techniques and principles to daily tasks and activities.

• Applies relevant regulations, standards, GxP requirements, and industry best practices to assignments.

• Plans and conducts projects and activities with moderate to high technical responsibility, complexity, and strategic input.

• Acts as a subject matter expert in routine quality engineering and scientific matters.

• Develops and drives key strategic quality engineering/scientific initiatives throughout the organization.

• Supports the execution of strategic vision or plan by collaborating with other quality partners to identify required quality engineering skills and competencies.

• The quality engineer will also be involved with quality systems initiatives as a primary assignment or additional assignment. Generally, the projects will involve potentially greater business impact in the following areas:

  • Business improvement

  • Quality systems

  • Lifecycle management

You will report to the manager for the Product Quality and Post Market Surveillance department.

Qualifications

• Bachelor’s or Master’s Degree in engineering, science, or related technical field is preferred

• 4+ years relevant experience in a regulated industry (medical device, biopharmaceutical, or pharmaceutical) is preferred

• Experience working with ISO 13485, FDA CFR 21 Part 820 and ISO 14971

• Leading and/or contributing to root cause investigations using various problem-solving techniques and tools and assessing the effectiveness of corrective actions

• Driving …