Job Description

The Quality Engineer, as part of a cross-functional team, with primary responsibility for quality management related to Operational support, ensures that applicable elements of the Quality System and external standards are being followed. As the voice of Quality, the Quality Engineer applies quality best-practices including team-based and statistical tools and techniques, strong root cause analysis skills, and promotes the value and use of such tools throughout the organization. This role will lead and execute projects of varying complexity and must be able to connect well with all levels of the organization from operators and inspectors to management. The role should require minimal oversight from management and possess strong root cause analysis skills.

Essential Job Functions

• Executes Quality Engineering activities in relation to Operational support, including support of risk management creation, classification of quality characteristics, technical drawings and specifications, design verification and validation, and process validation activities.
• Performs root cause analysis of identified issues and identifies appropriate corrective and preventive action. Supports NC and Complaints/CAPA/SCAR systems within QE Team.
• Uses appropriate statistical tools such as collecting and summarizing data, drawing conclusions with confidence, determining sample sizes, applying Statistical Process Controls (SPC), identifying relationships between variables, and statistical decision making.
• Supports activities related to clean room monitoring and environmental controls.
• Works closely with Quality Control team to ensure adequate resources to support manufacturing
• Ensures compliance with all practices in accordance with the Quality Management System.
• Provides technical support for process improvements, supplier changes or design changes including but not limited to creation or updates to risk management documentation, ensuring comprehensive documentation is available, adequate records are produced, and change management is implemented for such changes.
• Work with quality control, manufacturing, and warehouse personnel to implement processes and process improvements including related documentation
• Executes control measures and drives resolution when supplier quality issues are identified.
• Supports supplier management principles such as supplier selection, qualification, certification, and performance improvement.
• Applies the concepts of producer and consumer risk and related terms, including operating characteristic curves, AQL, LTPD, AOQ, AOQL, etc. Interprets and selects variable, attribute, and zero-defect sampling plans. Supports incoming inspection processes.
• Develops and validates test methods with oversight as needed. Identifies and applies metrology techniques such as calibration systems, traceability, measurement error, and control of standards and devices. Conducts measurement system error studies such as Gage R&R.
• Understands the implementation of appropriate internal, national, and international requirements and standards. Performs internal and external audits as necessary (virtual and in-person) including supplier audits
• Defines, identifies, and applies product and process control methods such as developing control plans, identifying critical control points, and developing and validating work instructions.
• Contributes to corporate technical programs (e.g., system improvement, remediation, harmonization) in areas such as those identified in this position description.

Requirements

Qualifications

Bachelor’s degree in a STEM discipline or equivalent experience required.

3-6 years’ experience in the medical device or pharmaceutical field preferred.

Technical knowledge and understanding of the medical device industry.

Must have experience in risk identification, mitigation, and risk management

Prior Supervisory experience is preferred

Experience with manufacturing processes and related documentation preferred

Experience with sterilization and packaging validation activities preferred.

Minitab experience preferred.

Experience in 3D modeling and drafting preferred.

Proven track record of executing multiple projects / initiatives simultaneously, exhibiting appropriate prioritization of tasks and completing them with a sense of urgency

Competencies

Self-directed, demonstrating ownership and accountability with an aptitude and willingness to learn.

Team-oriented personality

Demonstrates the ability to plan, execute, control, and deliver on project tasks and overall goals.

Strong written and verbal communication skills.

Excellent problem-solving skills

Strong organizational skills

Collaborative personality with the ability to lead and influence others effectively without authority while creating and maintaining a positive environment.

Ability to develop and maintain relationships with medical professionals, sales force, and cross functional team members.

Understanding of change management, conflict resolution and team dynamics.

Excellent critical thinking skills, including experience implementing the DMAIC thought process and structured root cause analysis, while employing a risk-based thought process.

Ability to identify project and design risks and create mitigation strategies.

Ability to independently make sound decisions with available information, through a risk-based approach.

Ability to analyze data using statistical methods.

Physical Requirements

Performing the duties of this job regularly involves sitting, standing; walking; hearing/listening, repetitive hand movement; vision requirements - close vision, adjust focus, color code

Mental Requirements

This position requires the ability to: maintain an appropriate work pace; comprehend and follow instructions; exercise logic and reasoning; organize and prioritize; read; compose written communication; communicate verbally; problem solve and make decisions; count and compute,) analyze and interpret data; multi-task/re-direct; experience numerous interruptions. This position requires the ability to maintain the highest standards of professional maturity and emotional intelligence even in difficult or stressful situations

Other Requirements

Some US travel may necessary (<10% time)

Work Environment

The noise level in the work environment is usually; (1) quiet to moderate. Occasionally this position will be in a lab or machine shop environment where the noise level will be loud.