JOB SUMMARY
Work under limited supervision to provide quality support by assisting management institutionalize compliance with global regulatory requirements. The Specialist must be capable of managing elements of the Quality Management Systems (QMS) to ensure timeliness of reports and compliance with the established standards. Providing support for audits, nonconformance investigations, or other services to this end may be required.
ESSENTIAL DUTIES
Organize and manage a Quality Survey system to provide requested feedback to customers.
Serve as the project coordinator for a given Quality System. Managing meetings involves the following responsibilities (as applicable): creating presentations, monitoring trends, analyzing data reports, ensuring timeliness on reports, writing/communicating meeting minutes, tracking action items, and presenting data to meeting attendees.
Works closely with quality management, manufacturing, engineering, regulatory affairs, and other functional groups on regulatory as well as quality system compliance issues.
Develops or participates in the development of solutions to problems of moderate to intermediate complexity. Interprets, executes, and recommends modifications to operating policies where appropriate.
Provides accurate and timely turnaround time on investigations, surveys, trend reports and other activities. Able to utilize technical writing skills to create or edit reports. Communicate effectively to management regarding those reports.
Organize and manage projects that typically will require ingenuity and evaluation as well as vendor and/or customer contact.
Fulfills FDA and international regulatory requirements relevant to each project such as GMP, IDE, PMA, 510(k), and ISO Standards.
Perform Periodic Review of Documents: manage or evaluate company Standard Operating Procedures (SOPs) intended to assure compliance with applicable global regulatory requirements and standards.
Comfortable directing or supporting internal or external audits (front room and backroom duties).
MINIMUM QUALIFICATION REQUIREMENTS
Education
Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
Experience
Minimum 4 years of experience.
Experience in a manufacturing environment preferred.
Skills
Time management and flexibility.
Demonstrated ability to routinely diagnose problems and recommend solutions through teamwork, failure mode analysis, and other analytical techniques.
Knowledge of manufacturing protocols, statistical tools and methodology, and continuous improvement techniques.
Demonstrate ability to communicate effectively both verbally and in writing.
Knowledgeable in international regulations relevant to each project, i.e., GMP, IDE, PMA, 510(k), and ISO.
Work assignments may require the development of in-depth engineering or technical writing skills.
Ability to organize and manage a multitude of projects.
Knowledge and use of relevant PC software applications (Outlook, Teams, Word, PowerPoint, Excel, etc.) and skills to use them effectively.
Or
An equivalent competency level acquired through a variation of these qualifications may be considered.
Additional Physical Requirements
May be required to travel domestically on some occasions
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