Job details
Job type full-time
Full job description
Mainstay medical
Mainstay medical is a medical device company focused on marketing an innovative implantable neurostimulation system, reactiv8®, for people with disabling chronic mechanical low back painThe company is headquartered in dublin, ireland, with subsidiaries operating in ireland, the united states, australia, germany, and the netherlands.
The role
Mainstay medical is seeking a driven and passionate senior quality engineer – post market qualityThis individual will be responsible for quality engineering activities to support post market surveillance and risk management processesResponsibilities also include supporting post market product changes, quality issues, validations, complaints, quality compliance and issue trending/reportingWe hope you will join us on this journey to reactiv8 life.
Position responsibilities
Good understanding of medical device regulation (fda, eu and international quality systems requirements (fda and iso 13485).
Support post market surveillance and risk management processes, which may include event reporting and complaint trending.
Familiarity with supply chain management and supplier development, risk management, and project management.
Support audits and continuous improvement activities.
Ability to work independently and with all levels of managers, associates, and teams.
Familiarity with design phases, including validation and verification, specifications, and sterilization a plus.
Complete all other related duties assigned.
Competencies
Teamwork – able to collaborate with all functions within an organization.
Integrity – handle confidential information in an effective manner.
Innovative – use creativity to problem solve and be agile to adapt to changing business.
Leadership – able to lead by exampleEstablish credibility within the organization and lead others when warranted.
Qualifications
B.sDegree in engineering, medical, biological, or related fields.
Certified quality engineer (cqe) / certified quality auditor (cqa)/ asq certification preferred.
Iso14971 training.
3+ years’ experience in quality assurance, including risk management and post market surveillance, quality systems, standards, metrics, and tools.
3+ years of experience in the medical device industry in the quality function
Advanced degrees will substitute for 1 year of experience.
Excellent verbal communication and interpersonal skills.
Demonstrated excellent organizational skills with attention to detail.
Proficient in computer operations, including microsoft word, outlook, excel powerpoint, and basic database management.
Problem solver and capable to find solutions to challenges.
Physical requirements:
While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle of feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locationsEmployee must occasionally lift and/or move up to 20 poundsAbility to travel by car or airplane independently up to 30% of the time and work after hours is required by travel schedule os business issues.
We hope you will join us on this journey to reactiv8 life!
Visit our company page: https://mainstaymedical.com/
Watch video testimonial from mainstay medical patients: https://mainstaymedical.com/patients/#testimonials
Come join a growing and thriving organization! we foster an exciting culture founded on teamwork, bias for action, urgency, and accountability, which allow us to develop meaningful and lasting relationships with our colleagues, the doctors and patients we serve.
We offer a competitive packageOur core benefits include: medical, dental, vision, 401(k) retirement savings, life and short-term disability, pto.
No search agents/agencies/recruiters
Position is not available for relocation assistance.
