Assists and supports the organization with initial compliance and ongoing preparation, testing, and monitoring of conformance to established quality assurance processes and standards for development and deployment. Performs evaluation of internal controls, communications, risk assessments, and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards. Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them. Facilitates internal training on quality assurance requirements, processes, and procedures. May perform audits and risk assessments.
The Sr. Quality Assurance Specialist is responsible for general support and maintenance of the Quality System within, but not limited to, the FDA's Quality System Regulation (QSR), ISO 13485 (ISO), and international quality requirements to assure compliance to regulatory agencies and the Quality System.
The ideal candidate for his position must have IEC62304 expertise.
Execution and completion of project deliverables utilizing critical and statistical thinking with methodologies to identify nonconformance and opportunities for improvement.
Ability to serve as a Quality resource/facilitator for audit programs including internal audits (routine and directed), and external audits (e.g. FDA, ISO, etc.) or inspections.
Analyzes complex production and quality trend data to identify and solve problems. Devises sampling procedures and designs and develops systems for recording, evaluating, and reporting quality and reliability data.
Participates on cross functional teams to assure effective implementation and adherence of QA initiatives and process improvement.
Ability to support the Quality System (e.g., create quality plans for initiatives, facilitate change orders, CAPAs, and internal audits).
Administer the CAPA program and participate in customer complaint investigations for incidents or events.
Provide Quality System training as required.
Monitor and maintain Quality System logs. Generate monthly and quarterly reports as assigned.
Provide assistance in maintaining training and competency records. Monitor for compliance. Work with supervisors to ensure new hires are assigned the appropriate training.
Provide assistance to maintain high quality standards and change control during new test launch, LIMS updates, and all process changes. Ensure all regulatory standards are met.
Provide assistance in maintaining Continuing education (CE) training compliance. Assist in development of updates to the training and competency program for CLIA/CAP.
Maintain records and proper documentation for QA Meetings, Quality, Management, and Annual Product Reviews. Follow up on action items.
Communicate and escalate any quality issues or concerns to management.
Other tasks as assigned.
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, skill, and/or ability required.
2 years minimum experience in a quality assurance role, 4 years preferred
Familiarity with Software Development methodologies such as Waterfall, Agile, SAFe, AAMI TIR45
Effective oral and written communication skills
Consistently neat and accurate reporting
High attention to detail
Excellent organizational skills
Proficient in MS Office applications
Excellent people skills: tact, collaborative, able to communicate with personnel at various levels in the organization
Assertive in enforcing department guidelines
Auditor experience or certification is a plus
Black belt or green belt in Six Sigma is a plus.
Bachelor Degree required. Focus in Computer Science, Software Engineering, Mathematics, Biological Sciences, Business Administration or related field is preferred.
Membership in a professional organization such as ASQ, AMP, or RAPS is considered a plus.
Scrum master certification is a plus.
Internal Number: 201812-131642
About Roche Molecular Solutions
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