Job details
Job type contract
Not provided by employer
Full job description
Contract (remote)
Position summary
Responsible for the development, maintenance, implementation and oversight of specifications and standards for processes, materials, and products in accordance with quality programs, plans, sops and policies of the company’s quality system and in compliance with fda regulations, eu mdr, iso 13485, iso 14971, and other regulatory requirements as applicable.
Qualifications
Bs or ms degree in technical/scientific/engineering discipline, with at least 4+ years of experience in medical devices, in vitro diagnostics or a related industryExperience developing and implementing quality plans and programsAsq certification (cqe, cre) is preferredWorking knowledge and experience of fda’s quality system requirements (qsr), iso 9001 and iso 13485 standardsAbility to coordinate multiple project schedules and activities.
The candidate should have strong analytical, communication and interpersonal skillsStrong linguistic, grammar, and editing skillsAbility to multi-task in an environment with changing prioritiesStrong statistical training, skills and experience.
Proficiency with microsoft applications word, excel, project, visio, and powerpointAnd ability to learn additional software applications, as the need arises.
Principal duties and responsibilities
Assist in the development, implementation, and maintenance of quality system specifications and requirements in accordance with cgmps, iso 13485 and other international regulations as applicable.
Direct and/or participate in projects directed at the development and implementation of quality standards throughout the company.
Participate in department meetings to provide input into the design and implementation of product specifications.
Write, review and edit documents and sops as required.
Facility and system oversight during fda inspections, iso certification and surveillance audits and customer and supplier audits.
Interfaces with all departments with special regard to quality systems regulations {iso 9001, iso 13485, iso 14001 and qsr 21 cfr part 820}
Provides technical and logistical guidance and support for the quality engineering staff
Drives proactive participation with suppliers, and aids, when applicable, in their process improvement efforts
Interfaces and provides technical support on quality issues with the customer
Assist in validation and verification activities and development of requirements and specifications.
Follow-up on corrective action responses, ensuring implementation of appropriate problem resolution methods and verifying effectiveness.
Facilitates problem-solving activities, team building and quality systems tools and methodologies.
Collaborate with other departments and functions on continuous improvement opportunities of the quality system.
Carry out other duties as required or assigned
To apply for a job listed, please send a cover letter and resume to careers@emmainternational.com.
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Job activity
Posted 30+ days ago
