Senior Quality Engineer at Biomerics

Santa Clara, California, United States -

Full Time

Start Date

Immediate

Expiry Date

07 Apr, 26

Salary

0.0

Posted On

07 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Engineering, Process Development, Validation, Risk Management, Root Cause Analysis, CAPA, Statistical Tools, Medical Device Design, Manufacturing Processes, Problem-Solving, Analytical Skills, Communication Skills, Interpersonal Skills, Project Management, Teamwork, Leadership

Industry

Medical Equipment Manufacturing

Description

Description Company 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 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. Job Description 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. Job 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 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 Biomerics offers the following benefits: Medical/Dental/Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance, Paid Vacation Days, 9 Paid Holidays, and 401k. Please, No Recruitment Agency calls or emails (we are not using recruitment services for this or any other role posted). The salary estimates are estimates from this job board and not a guarantee from Biomerics salary range. Biomerics does not accept non - solicited resumes or candidate submittals from search/recruiting agencies that are not already on Biomerics' approved agency list. Unsolicited resumes or candidate information submitted to Biomerics by search/recruiting agencies not already on Biomerics approved agency list shall become the property of Biomerics. If Biomerics subsequently hires the candidate, Biomerics shall not owe any fee to the submitting agency.

Responsibilities

The Senior Quality Engineer will provide leadership in developing and maintaining Quality Engineering methodologies and practices. Responsibilities include participating in product development, developing control plans, and leading risk management activities.