- The QA/RA Manager provides leadership to internal staff and is assigned the authority to implement, coordinate, and monitor the facility’s quality and regulatory system. S/he acts as the company’s FDA submission coordinator and ISO management representative. The RA/QA leads the quality system contact for internal and external audits, and internal information related to the quality system.
- Essential Duties and Responsibilities:
- Coordinates manufacturing quality control.
- Coordinates with internal and external parties to manage the compilation of content from R&D, Manufacturing, and Management in order to create and see to completion of new FDA submissions – including 510(k) submissions.
- Ensures that FDA rules and regulations are adhered to.
- Maintains a working knowledge of regulations and establishes a monitoring program that responds to audit activity in a constructive manner.
- Provides facility Quality Systems and Regulatory Compliance leadership and administration by ensuring all relevant Food and Drug Administration (FDA) regulations, Corporate policies, current ISO registration requirements, AAMI/ANSI/ISO 11137/11135 and EN 550/552, EN 46000 and other appropriate standards are met
- Implements and communicates new or revised Quality System/Regulatory Compliance policies and procedures.
- Ensures that all processing records are in compliance with processing specifications and Quality Systems (QS)/Regulatory Compliance (RC) requirements prior to product release.
- Ensures that company personnel are appropriately trained and that training is documented according to Quality System policies and procedures.
- Supports a safe, clean and secure working environment by supporting procedures, rules and regulations.
- Supports manufacturing and lab safety committees that evaluate plant machinery, equipment and working conditions.
- Has authority and responsibility to represent the facility on all FDA submissions and quality matters pertinent to the quality management system as established through regulatory requirements as well as organizational quality policies and procedures.
Authorities for Position
- Experience manufacturing quality control.
- Experience with FDA 21 CFR 820 strongly desired.
- Experience with ISO 13485:2003 standard strongly desired.
- Experience with FDA (i.e. 510(k) applications, IDE submissions) a plus.
- Effective with written and oral communication.
- Ability to work independently under general guidelines and supervision.
- Computer skills and word processing, spreadsheet and software capabilities.
- Effective interpersonal skills as demonstrated through prior management experience.
Qualifications Required for Position
- Bachelor’s degree required.
- Preference is given for ASQ certification and/or advanced degrees.
- Experience in medical device manufacturing, sterilization operations, and Quality System FDA regulations (QSR) and validation is preferred.
- AAMI industrial sterilization methods experience preferred and experience with statistical technique such as SPC and experimental design experience preferred.
To apply for this position, please send your resume, cover letter and references to firstname.lastname@example.org.