Senior Quality Engineer

Biomerics•Brooklyn Park, MN

65d

About The Position

The Senior Quality Engineer will play an important role within the Biomerics Extrusion, Metals, and Plastics team, providing Quality Engineering leadership in developing, establishing, and maintaining Quality Engineering methodologies, systems, and practices, which meet internal, customer, and regulatory requirements.

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.
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 (e.g., CQE, CQA) are preferred

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
Leading 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
Leads preparation of risk management files and reports for product releases, and has 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