Farm, a Flex company with over 50 years of experience in providing award-winning development services for medical, life sciences, and consumer healthcare sectors, is seeking a Sr. Quality Engineer based in Hollis, New Hampshire.
The Senior Quality Engineer is responsible for supporting quality-related activities on development teams at Farm. The Senior Quality Engineer works with the development team to support development activities from a Quality engineering perspective, ensures that the development team is compliant with the policies and procedures of Farm’s Quality Management System (QMS), approves documentation created during the development process and supports the Farm ISO 13485 certified QMS.
The Senior Quality Engineer receives direction from the Director of Quality and input from Program Managers while working on development teams.
Here is a glimpse of what you’ll do:
Support product development as an embedded program team member working alongside program managers, researchers, human factors engineers, designers, mechanical engineers, and electrical engineersProvide guidance to program teams on compliance with the quality management systemAssist program managers with development, review, approval, and updates to program documentsAssist program managers with development, review, and updates to program and quality planning documentsCollect and manage content of program design history files (DHF)Review applicability of customer product requirements and risk management documentation to programs and deliverablesCoordinate milestone and technical reviews with program teamsCollaborate with program teams for planning and documentation for prototype builds including, but not limited to control of the design; development of build plans; acceptance of materials and documentation of assembly processesLead planning and documentation for prototype testing including, but not limited to creation of test plans; development of test methods; coordination of data collection, analysis & audit, and completion of test reportsManage quality management system processes including, but not limited to training records, calibration records, supplier records, engineering change orders (ECO) and documentation controlEstablish, evaluate, qualify, encourage use of and continuous improvement to processes, procedures and standard tools used by program teamsParticipate in internal, customer and notified body audits of the quality management systemLead corrective action and preventive action resolutionInteracts with customers, suppliers, and external auditors to develop close working relationships.Participates in customer strategy meetings and discussions regarding the development of program quality requirements and plans.Participates in the design review process on development programs.The experience we’re looking to add to our team:
Bachelor's degree in Engineering or related field or equivalent experience and training.4+ years of quality experience .2+ years of medical devices experienceISO13485/ FDA/ 21cfr 820.30Previous product development / design control experienceISO 13485 Internal or Lead Auditor Training (Preferred)What you'll receive for the great work you provide:
Full range of medical, dental, and vision plansLife InsuranceShort-term and Long-term DisabilityMatching 401(k) ContributionsVacation and Paid Sick TimeTuition ReimbursementJob CategoryDesign, Process & Technology EngineeringIs Sponsorship Available?
NoFlex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We celebrate diversity and do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email accessibility@flex.com and we'll discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex, you must complete the application process first).