Senior Quality Specialist

Senior Quality Specialist

Requirements

• Bachelor’s Degree or an equivalent combination of education and experience
• 5 years relevant experience, such as Quality, Compliance, Engineering, within a regulated environment, such as medical device, diagnostics, or pharmaceutical industries, to develop the competence required to meet the skills and responsibilities of the position.
• Knowledge of applicable US and non-US Quality System Requirements and other relevant regulations for medical devices. Previous experience with regulatory body.

Responsibilities

• Independently lead groups and projects to resolve complex issues. analyze complex problems and identify their impact. establish probabilities. draw conclusions reflecting broad business needs. ensure compliance.
• Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
• Establish regulatory reportability decisions using event investigation and regulatory decision models.
• Write Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities.
• Compose written communications detailing the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to end use customers or regulatory bodies
• Cross-functionally lead alignment between departments and/or divisions which may include complaint handling, customer service, medical events, and product quality.
• Cross-functionally lead Quality System process improvements which may include training, corrective action and preventive action (CAPA) activities, equipment maintenance, product and process planning, quality audits, validation, product development/clinical research, design control activities, complaints, and post market surveillance.
• Work may require collaboration with other Division sites and/or other Abbott divisions.
• Responsible for completing documentation in a timely manner and in accordance with business standards.
• Understand and comply with applicable EHS policies, procedures and guidelines.
• Works under general direction; independently determines and develops approach to solutions; work is reviewed upon completion for adequacy in meeting objectives.
• Makes timely and effective decisions related to business issues within scope of responsibility; appropriately elevates high risk issues / decisions; identifies and quantifies risks and their consequences relative to the success of a project / task; recommends appropriate action; decisions or recommendations would typically achieve departmental / project objectives.
• Drives functional performance that ensures cross-functional standards and expectations are met
• Travel up to 10% of the time both domestically and internationally to support organizational goals

Preferred Qualifications

• Knowledge of software regulations and compliance (21 CFR Part 11)
• Knowledge of ISO 13485; knowledge of consumer regulations a bonus.
• Knowledge of quality management techniques and the application and principles of quality engineering. Strong knowledge and application of concepts, practices and procedures. Ability or aptitude to work on problems that are complex in scope where analysis of situations or data involves multiple competing factors. Understanding of statistics.
• Ability to form and develop interpersonal, professional relationships; display socially and professionally appropriate behavior.
• Ability to work independently and in groups; ability to work cross-functionally.
• Demonstrated initiative and problem-solving skills and critical-thinking skills.
• Ability and aptitude to use various types of databases and other computer software.
• Ability to prioritize. Strong organizational and project management skills.
• Ability or aptitude to lead without direct authority