Position Summary
Assist RA/QA Manager with selected aspects of Quality Assurance and Regulatory Affairs.
This job is an at-will position. Employment in this job is not for any fixed period of time, and either the Company or the employee may terminate employment at any time, with or without advance notice, and with or without cause. The Company may change the terms or conditions of employment at any time.
Essential Duties and Responsibilities
This job is an at-will position. Employment in this job is not for any fixed period of time, and either the Company or the employee may terminate employment at any time, with or without advance notice, and with or without cause. The Company may change the terms or conditions of employment at any time.
Essential Duties and Responsibilities
- Assist in completing various quality and regulatory tasks relevant to medical device manufacturing and distribution including, but not limited to, incoming raw material and finished device inspections, review, investigation and disposition of nonconforming products individually and via MRB, manufacturing controlled environment monitoring, audit of finished device history records for completeness, legibility and compliance.
- Serve as Material Review Board Administrator ensuring that Non-Conforming Material Reports are investigated, properly documented, and completed such that product is dispositioned appropriately.
- Maintain files for critical raw material/service provider supplier audits, notified body audits, internal audits, pest control inspections and controlled supplier assessment files.
- Review and perform final release of finished product Device History Record (DHR) files including finished device labeling and sterilization documentation for compliance to established specifications.
- Generate and audit distributed product Certificates of Compliance and associated sterility records when required by customers.
- Serve as Environmental Controls Administrator ensuring that clean room/manufacturing areas are properly monitored to meet regulatory requirements, and that out-of-specification results are properly corrected / prevented
- Log, analyze and trend facility temperature and humidity monitoring and facility pest control monitoring
- Assist in preparation of management review reports
Developmental
- Stays current with all procedural updates by attending training sessions.
- Successfully complete yearly assigned Training Needs Analysis and Training Plan objectives
Job Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills and/or abilities required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
1.Education/Qualifications
1.1.Bachelor’s degree in engineering or other technical sciences, or comparable experience working in the medical device industry, Quality Assurance, Regulatory Affairs, Compliance or Development.
1.2.Knowledge of quality tools/sampling plans/problem solving/statistical process control/design of experiments.
1.3.Knowledge of ISO 13485:2016 and/or FDA 21 CFR 820 experience preferred.
2. Experience
2.1Relevant experience in Quality Assurance, Regulatory Affairs, Compliance or Development in an FDA regulated environment. Three (3) Years minimum in the medical device industry preferred.
At least one (1) year experience with CAD software (Autodesk or similar)
applications preferred.
3.Aptitude
3.1.Ability to add, subtract, multiply and divide accurately. Ability to measure and count in English standard and Metric units. Ability to read and interpret component and device drawings/schematics.
Ability to apply common sense understanding to carry out detailed written or oral instructions.
Ability to deal with problems involving a few concrete variables in standardized situations.
4.Operational Skills
Ability to read and comprehend instructions, correspondence and memos.
Ability to write simple correspondence and fill out paperwork as required
Ability to interpret a wide variety of instructions furnished in oral, written, diagram, or schedule form.
Ability to effectively present information in one-on-one and small group situations to customers, clients and other employees in the organization.
5.Physical Demands
5.1 The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
5.2 While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand, sit and reach with hands and arms. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, color vision and depth perception.
Work Environment
6.1The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
6.2 While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts. The employee is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals and electrical shock. The noise level in the work environment is usually quiet.