Senior Quality Engineer

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Overview

Biomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech industries. As a vertically integrated company, we design, develop, and produce medical devices for diagnostic and interventional procedures. We focus on next generation solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.

Biomerics is committed to a diverse employee base and a culture that emphasizes integrity, partnership, empowerment, accountability, trust, agility, teamwork, and excellence. We strive to live Biomerics value in all interactions and to improve the lives of our employees and the patients who depend on our products.

Job Type : Full-time

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 reports to gain approvals
• 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 the creation, release, and maintenance of DHR, Bill of Materials, and manufacturing specifications
• Review and approve product documentation
• Lead the preparation of risk management files and reports for product releases; assume primary responsibility for risk management activities from 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 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

Qualifications

Education

Experience

Knowledge

Certifications

Other

Benefits

Biomerics offers Medical / Dental / Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance, Paid Vacation Days, 9 Paid Holidays, and 401k.

Important notices

Please, no recruitment agency calls or emails (we are not using recruitment services for this or any other role posted).

The salary estimates are provided for reference by this job board and are not a guarantee from Biomerics.

Biomerics does not accept unsolicited resumes or candidate submittals from recruitment agencies not already on Biomerics\' approved agency list. If Biomerics hires a candidate submitted by an unapproved agency, no agency fee will be owed.

Salary Description

$110,000-115,000

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