The Sr. Quality Assurance / Quality Control Specialist is a central role in the ICON medical device team in Pleasanton, CA. This is a hybrid QA/QC role. We are looking for a closure-oriented QA specialist that wants to include QC responsibilities in their daily routine to maintain a close connection to production, or a detail-oriented QC specialist that is interested in expanding their role to the implementation and operation of the QMS.
Essential Job Duties and Responsibilities:
Essential responsibilities and duties include, but are not limited to, the following:
- Administer digital QMS processes including Document/Change Control, CAPA, Complaint, NCR, and Internal Audit programs.
- Enter Complaints and prepare materials for the monthly Complaint Review Board
- Compile and review key QMS indicators and performance data of quality systems to assess their continued suitability, adequacy, effectiveness, and efficiency, and issue periodic reports to management.
- Perform final quality control inspection of ICON products to ensure medical device conformance prior to release to finished goods.
- Perform incoming quality inspections of ICON related parts following established inspection procedures to ensure received material conforms to specification.
- Communicate quality information to all relevant departments, outside vendors, or contractors in support of the QA/RA and manufacturing teams.
- Support the Director of RA/QA to ensure all quality standards and regulatory requirements are met, and compliance is maintained, with all local, state, federal, and applicable international regulations.
- Additional duties as required.
Job Qualifications and Education:
- Bachelor of Science degree or equivalent in molecular biology, chemistry, life sciences or medical device engineering.
- Minimum of 4 years of experience in a QA/QC role.
- Strong working knowledge of quality systems, Good Manufacturing Practices (GMP), and ISO standards (9001 or 13485) with start-up experience preferred.
- Understanding of risk management principles and ability to apply these principles in day-to-day quality management activities, quality and compliance issues, and business challenges.
- Critical thinker with the ability to read, analyze, and interpret technical data.
- Ability to lead, train, motivate, and work effectively within a team.
- Excellent spoken and written interpersonal communication skills including the abilty to work effectively with a distributed team.
- Good conceptual, analytical, problem solving, planning, and organization skills, including demonstrated prior accomplishments.
- Ability to multi-task and wear multiple hats, assisting departments as needed.
- Ability to prioritize and adapt to changing priorities while maintaining a high-quality standard.
- Proficient in Microsoft Office (especially Word, Excel, and PowerPoint).
- Experience with Arena QMS preferred
Other duties as assigned by management.
Knowledge, Abilities, and Skills:
- Candidate must have minimum 4 years medical device industry experience.
- Candidate likely has a strong QC background and has performed quality testing and inspection.
- Candidate must have working knowledge of Arena or other digital Quality Management Systems. (Agile, Arena, Greenlight Guru, etc.)
- Strong knowledge and competence in 1) application of FDA-Quality System Regulation (21CFR820) 2) medical device complaint handling and MDR/Vigilance reporting requirements, and 3) ISO 13485 quality system management requirements.
- Knowledge of Federal Food, Drug and Cosmetic Act; Code of Federal Regulations; FDA guidelines.