Sr Quality Engineer - Exempt

We are seeking a highly skilled candidate for an immediate opening to backfill an employee during a mandatory time-off period. This is a short-term position lasting 3 months, with responsibilities across multiple projects impacting various product lines.
Must Have

• Bachelor's degree in Engineering, Science, or a technical field with a minimum of 4 years of experience in Engineering and/or Quality, or an advanced degree with 2 years of relevant experience.
• Experience in Validation/Qualification activities: writing, coordinating, executing, creating reports, IQ, OQ, PQ, MVPR, etc.
• Experience in Risk Documentation: writing, reviewing, approving Risk Management files, RPM calculations, Risk Mitigations, etc.
• Strong statistical background and sampling size determination for attribute or variable data.
• Ability to work with minimal supervision in a hybrid working setup.
• Excellent writing, documentation, organizational, and verbal communication skills.
• Ability to work in a fast-paced environment and meet deadlines.
• Ability to interact with a diverse team while maintaining high ethical standards.
• Commitment to the company's core values.
• Strong Risk Management Experience.

Nice to Have

• ASQ Quality Engineer Certification.
• Bilingual in English/Spanish preferred but not required.
• Previous experience in the medical device industry.
• DMAIC Lean / Six Sigma Certification.
• Manufacturing experience within a controlled and regulated industry.

Responsibilities

• Provide Quality Engineering support to multiple projects, including supplier quality engineering support.
• Conduct day-to-day Risk Management reviews and maintain strong Risk Management practices.
• Develop, execute, analyze, and report on validation/qualification activities such as IQ, OQ, PQ, MVP, and Test Method Validations.
• Evaluate, review, and update quality records, including design files and process documents, ensuring compliance with ISO standards and local procedures.
• Oversee the development and maintenance of quality programs, systems, processes, and procedures to ensure compliance with internal and external standards.
• Provide expertise and guidance in interpreting policies and regulations to assure compliance.
• Work with various internal and external entities to provide quality engineering and supplier quality engineering support.
• Prepare reports and necessary documentation for project stakeholders.
• Develop and apply quality standards and protocols for material processing.
• Implement inspection, testing, and evaluation methods for product precision and accuracy.
• Ensure corrective measures meet reliability standards and documentation requirements.
• Support multiple projects in areas such as design, production control, and research and development.
• Perform Root Cause Investigation using quality tools when required.
• Collaborate with cross-functional teams to resolve process issues and implement changes.
• Apply process control tools and statistical sampling techniques to enhance product quality and flow.
• Identify, analyze, and manage risk throughout the product life cycle using risk management tools.

Differentiating Factors
Autonomy: Operates independently under limited supervision, coaching lower-level specialists and potentially managing projects.
Organizational Impact: Responsible for projects or processes, contributing to work group objectives through collaboration and consensus building.
Innovation and Complexity: Solves complex problems, improves processes, and provides in-depth analysis with recommendations.
Communication and Influence: Communicates with senior internal and external stakeholders, exchanging information to achieve objectives and influence decisions.
Leadership and Talent Management: Provides guidance and training to other employees, manages projects, and delegates work as needed.
Required Knowledge and Experience: Requires advanced knowledge of the job area, typically obtained through an advanced education combined with experience. Practical knowledge of project management is beneficial. Requires a University Degree and a minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years of relevant experience.