POSITION SUMMARY Responsible for identifying, leading, and/or supporting quality, regulatory, and compliance improvement initiatives, projects, and remediation activities at site, cross-site, and Business Unit levels. Manages cross-site data collection, analysis, and/or reporting as assigned. RESPONSIBILITIES: ESSENTIAL DUTIES AND RESPONSIBILITIES - (KEY ACTIVITIES)
- Reporting to the Director, Toxicology Quality Assurance, supports the development, implementation, improvement, and/or effectiveness of assigned site Quality Management Systems in compliance with applicable ISO, FDA, and other regulatory agency regulations and standards.
- Where assigned, ensures the development, improvement, and implementation of efficient, effective, and compliant processes, procedures, and systems that incorporate best practices and risk mitigation strategies.
- Manages assigned cross-site data collection, gap assessment, and analysis projects and reports results to site and/or Business Unit leadership. Provides, and may execute, suggested remediation activities.
- Collaborates with assigned sites on gap analysis and/or remediation activities that further development and implementation of QMS subsystems, including internal audit, validation, risk management, document control, distribution control, etc.
- Develops quality and compliance tools as aids in assessing QMS impacts of new regulations, standards, or policies.
- Leads or assists internal and external audits as assigned.
- Carries out duties in compliance with established business policies.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
- Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
- Perform other duties and projects as assigned
Requirements To be considered an applicant for this position you must show how you meet the basic qualifications of the job in a resume or document you upload, or by completing the work experience and education application fields. Accepted file types are Microsoft Word (DOC or DOCX), PDF, HTML, or TXT. BASIC QUALIFICATIONS:
- BS/BA degree in Biological/Life Sciences, Engineering or related field.
- A valid driver’s license and the ability to rent cars from commercial car rental agencies is mandatory.
- Ability to travel up to 25-50% of time for divisional assignments and audits. A majority of travel will be domestic but ability to obtain a passport for international travel is required.
- Minimum of five years of experience in the medical device industry with exposure to quality and manufacturing processes. Has an in-depth understanding of quality management systems, manufacturing processes, and materials.
- Minimum of five years of medical device industry experience with strong working knowledge of quality audits, both internal and supplier, 21 CFR 820, part 803, part 806, part 11; ISO 13485; GMPs; and other applicable international standards.
- Strong analytical, written, and verbal communication skills and the ability to articulate complex quality and regulatory matters with persons of a variety of backgrounds.
- Advanced computer software skills with word processing, database management, and data analysis. Knowledge of contemporary statistical analysis package(s) is preferred.
- ASQ Certification (CQA, CQE) or equivalent quality auditing experience is desired.
- Excellent verbal communication and presentation skills appropriate for acting as a liaison between company and its suppliers. Must be comfortable making accurate assessments and decisions with limited time during an audit. Must be able to determine important data to obtain and resolve barriers to obtaining it.
- Effective organizational and time management skills.
- Must have capability to review, analyze, summarize and interpret quality systems data, draw conclusions, make appropriate decisions and recommendations, write reports and give oral presentations.
- Must show self-initiative but be comfortable in the role of a team player. Must be able to work independently with minimal supervision.