Senior Quality Engineer

Biomerics LLC•Salt Lake City, UT

About The Position

The Senior Quality Engineer will provide Quality Engineering leadership for the Biomerics Extrusion, Metals, and Plastics team. The role develops, establishes, and maintains Quality Engineering methodologies, systems, and practices that meet internal, customer, and regulatory requirements. It supports product development, product introductions, design changes, manufacturing, validation, risk management, audits, and continuous improvement. The Senior Quality Engineer also leads investigations and provides leadership and mentoring to other Quality team members.

Requirements

Bachelor's degree in Engineering, Quality, or a related field, or equivalent experience.
Minimum of 5–7 years of Quality Engineering experience within a medical device manufacturing environment.
Working knowledge of process development and validation.
Strong knowledge of Quality Systems and regulations, such as FDA QSRs, ISO 13485, and ISO 14971.
Experience with root cause analysis, CAPA, and risk management.
Familiarity with statistical tools and methods.
Knowledge of medical device design and manufacturing processes.
Strong problem-solving and analytical skills.
Excellent communication and interpersonal skills.
Proficiency in Microsoft Office and Minitab.
Ability to work independently and as part of a team.
Strong organizational and project management skills.

Nice To Haves

ASQ certifications, such as CQE or CQA.

Responsibilities

Participate in product development teams, providing Quality input and support.
Develop and implement Control Plans, Master Validation Plans, and Inspection Procedures.
Develop validation strategies and ensure applicable requirements are met, from planning and protocol definition through execution, analysis, reporting, and approval of final reports.
Lead the development and results analysis of validation plans (IQ/OQ/PQ), Test Method Validation (TMV), Gage R&R, and test protocols to qualify and validate existing product designs, processes, and equipment.
Determine and recommend sampling plans, equipment requirements, measurement techniques, and training requirements to ensure specific quality levels.
Support new product introductions and design changes.
Support Manufacturing Engineering in creating, releasing, and maintaining DHR, Bills of Materials, and manufacturing specifications.
Review and approve product documentation.
Lead preparation of risk management files and reports for product releases, and take primary responsibility for risk management activities from product conception through commercialization.
Ensure risk management processes are followed and documented.
Ensure compliance with Biomerics quality standards, policies, and procedures.
Support external customer and regulatory agency audits.
Maintain clear, consistent communication with customers and teammates about expectations.
Lead investigations for nonconformances and customer complaints.
Use problem-solving tools to analyze issues, identify root causes, and implement corrective actions.
Identify process-improvement opportunities and implement solutions.
Monitor quality performance metrics and trends.
Provide leadership and mentoring to other Quality team members.
Promote a culture of quality, compliance, and continuous improvement.