The Quality Systems Compliance Specialist is responsible for supporting the daily operations of the Patterson Quality Management System. Supports the compliance activities with responsibility for results in terms of ongoing effectiveness of the QMS and of conformance to applicable regulation, standard and company policies.

Major Duties:

• Supports daily operations of the QMS for compliance to requirements of applicable regulation and standard, including 21 CFR Part 820, ISO 13485 and others as applicable
• Proposes and implements improvements to the QMS and its procedures and processes to maintain ongoing effectiveness
• Daily management of Corrective and Preventive Action (CAPA) and Supplier CAPA records from initial investigation and root cause analysis, into action planning and effectiveness in a timely and compliant manner
• Daily management of complaint activities including vendor and customer communications; documentation; review; investigation; and reporting in a timely and effective manner
• Supports field action risk assessment, bounding, inventory control, communications, effectiveness checks and reporting/closure
• Supports controlled documents and records including but not limited to design history, risk and supplier files; responsible for organization and retention of electronic/paper documents and records related to QMS
• Quality system metrics in support of management review
• Participates in internal/external audits
• Supports with gathering information for regulatory submissions, registrations and licensing applications as applicable
• Knowledgeable in data entry systems such as FDA FURLS, GUDID, Health Canada, EUDAMED

• Helps to interpret and apply regulatory and quality requirements; uses a risk-based approach to enable effective decision-making

• Stays current on industry trends in relation to compliance
• Provides support and contributes to other compliance activities and areas as necessary
• Other duties as assigned
• Occasional travel required

Qualifications:

• Bachelors Degree in Engineering, Science or related field or equivalent work experience
• 0-4 years’ experience with quality management systems and regulatory compliance in the medical device or related regulated field
• Developing working knowledge of quality management systems and regulatory submission requirements, preferably in an FDA-regulated environment (FDA 21 CFR Part 820 and ISO 13485 requirements)
• Demonstrated ability to review and quickly assimilate complex regulatory compliance information and standards
• Ability to work effectively within a team and as an individual contributor in a fast-paced changing environment - multi-tasks, prioritizes and meets deadlines in timely manner
• Strong verbal and written communications with ability to effectively communicate at specialist and line management levels in the organization
• Strong organizational, analytical, and creative problem-solving skills and track record contributing to team work practices with a moderate impact on functional objectives
• Highly self-motivated and directed and able to carrie out responsibilities with latitude and limited supervision
• Ability to prioritize and execute tasks in a high-pressure environment
• Strong customer service orientation
• Experience working in a team-oriented, collaborative environment