Summary: The Quality Engineer will lead efforts to maintain a culture focused on quality and continuous improvement across all departments. This role ensures that customer, company, and regulatory requirements are met while balancing cost and productivity goals. The Quality Engineer is responsible for developing, improving, and qualifying manufacturing and inspection processes, applying risk-based methods, and solving quality issues such as nonconformances and customer complaints. This position also involves creating and documenting process risk assessments, quality plans, and control plans.
Additionally, the Quality Engineer provides technical support to various departments, including supplier management, change management, and equipment control. They are a key resource for using statistical techniques and validation activities, such as statistical process control, risk-based sampling, and capability studies. Occasionally, they may assist with Quality System Compliance during internal, supplier, and external audits.
Quality Engineering Levels: A subject matter expert in Quality Engineering, skilled in various methodologies, who works independently and offers mentorship or supervision within the department. They demonstrate strong leadership, decision-making, technical writing, and critical thinking skills, particularly in risk management, to ensure business objectives are achieved.
Duties/Responsibilities:
- Adheres to all Quality Management System requirements and encourages others to do the same.
- Delivers on commitments with accuracy and attention to detail.
- Keeps up-to-date with relevant medical device regulations (e.g., FDA QSR, ISO 13485).
- Depending on assignment, the engineer will support either or both of these teams:
- Development-Customer Focused Team: Works as a quality representative to ensure customer, company, and regulatory requirements are met during the development and qualification of processes. Collaborates with customers and project teams to translate requirements into process specifications and validate test methods. Provides on-the-floor support during manufacturing runs.
- Collaborates with various departments to create, document, and implement:
- Risk assessments (PFMEAs)
- Quality Plans and Control Plans
- Production and inspection procedures
- Test method development and validation
- Equipment qualification protocols and reports
- Process characterization and statistical process controls
- Communicates potential product issues and nonconformances, ensuring they are documented according to company procedures.
- Provides technical expertise and applies Root Cause Analysis to resolve product and process issues.
- Supports continuous improvement initiatives, including CI and Lean, and may lead related projects.
- Conducts risk assessments for new and modified processes and updates documentation as needed.
- Offers technical expertise for various quality processes and supports external audits as necessary.
Training/Education/Experience:
- Bachelor’s degree in science, engineering, or a related technical field for Sr. QE or higher.
- Experience in medical devices or related fields is highly desired.
- Proficiency in statistical techniques, data management, and technical writing.
- Strong communication skills and a team-oriented mindset.
- Critical thinking and a commitment to continuous learning.
Competencies/Attributes:
- A "Humble, Hungry, and Aware" team player is preferred.
- Strong written and verbal communication skills, able to present to all organizational levels.
- Self-starter with attention to detail and the ability to manage multiple projects.
- Proficiency in Microsoft Office, ERP, and statistical software.
- Ability to create and present data clearly.
