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About the Role

The Senior Quality Engineer will provide Quality Engineering leadership in developing, establishing, and maintaining Quality Engineering methodologies, systems, and practices that meet internal, customer, and regulatory requirements within the Biomerics Extrusion, Metals, and Plastics team.

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, ensuring all applicable requirements are met from planning, protocol definition, leading execution of protocols, analyzing and reporting results, and completing report and gaining necessary approvals to close.
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 that will ensure specific quality levels.
Support new product introductions and design changes.
Support Manufacturing Engineering in the creation, release, and maintenance of DHR, Bill of Materials, and manufacturing specifications.
Review and approve product documentation.
Lead preparation of risk management files and reports for product releases, and have primary responsibility for risk management activities from product conception through commercialization.
Ensure risk management processes are followed and documented.
Ensure compliance to Biomerics quality standards, policies, and procedures.
Support external customer and regulatory agency audits.
Maintain consistent dialogue with customers and teammates to ensure clear communication and expectations.
Lead investigations for nonconformances and customer complaints.
Utilize problem-solving tools to analyze and identify root causes and implement corrective actions.
Identify opportunities for process improvement and implement solutions.
Monitor quality performance metrics and trends.
Provide leadership and mentoring to other Quality team members.
Promote a culture of quality and foster a culture of compliance and continuous improvement.

Requirements

Bachelor's degree in Engineering, Quality, or a related field or equivalent experience.
Minimum of 5-7 years of experience in Quality Engineering within a medical device manufacturing environment.
Working knowledge of process development and validation.
Strong knowledge of Quality Systems and regulations (e.g., FDA QSRs, ISO 13485, 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.
ASQ certifications (e.g., CQE, CQA) are preferred.
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.

Skills

Process development
Validation
Quality Systems
FDA QSRs
ISO 13485
ISO 14971
Root cause analysis
CAPA
Risk management
Statistical tools
Medical device design
Manufacturing processes
Problem-solving
Analytical skills
Communication skills
Interpersonal skills
Microsoft Office
Minitab
Organizational skills
Project management skills

Experience Level

5-7 years

Education Level

Bachelor's degree in Engineering, Quality, or a related field or equivalent experience

About the Company

Biomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech industries.
As a vertically integrated company, we specialize in designing, developing, and producing medical devices for diagnostic and interventional procedures.
We are focused on next-generation solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.
At Biomerics, we are dedicated to our diverse employee base.
We understand that a strong, skilled, and engaged workforce is the foundation of our continued success as a business.
We strive to live up to Biomerics' values in all our interactions.
It is an exciting time to be part of our collective team, and there is no limit to the impact that can be achieved here at Biomerics.
We improve and advance the lives of our employees and the patients who depend on our products.
At Biomerics, we believe in integrity, partnership, empowerment and accountability, trust, agility, teamwork, and excellence, and we care.
Our team-oriented, customer-focused corporate culture prioritizes building strategic, mutually beneficial partnerships with customers and our team members.