Senior Quality Control Engineer

Company Overview

Biomerics provides contract manufacturing, laser processing, and finishing services to a wide range of industries with a strong commitment to customer service.
Biomerics specializes in the most challenging machined and micromachined components, including those used in interventional and medical robotics applications. We pride ourselves in providing a supportive, positive work environment with opportunities for challenge and growth.

Biomerics offers Swiss machining with integrated laser cutting on precision medical tubing. Laser/Swiss machining enables features to be machined and laser cut in the same process. Our core competency lies in smaller medical components, produced with high accuracy and repeatability. Traditional Swiss screw machining capability is also available for rapid prototyping and production.

In addition,
Biomerics utilizes 5 axis milling machines capable of producing complex finished components, while holding extremely tight tolerances.

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.

• 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 process 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

• Bachelor's degree in Engineering, Quality, or a related field or equivalent experience
• 5+ 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 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

Medical/Dental/Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance, Paid Vacation Days, Paid Holidays, 401k

Equal Opportunity

Employer:

Minority, Female, Protected Veteran, Individual with Disabilities are encouraged to apply.

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

Biomerics does not accept non-solicited resumes or candidate submittals from search/recruiting agencies 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 and if Biomerics subsequently hire the candidate, Biomerics shall not owe any fee to the submitting agency.

The salary estimates are estimates from this job board and not a guarantee from Biomerics salary range.