Susan Reilly Email & Phone Number

United States

Boston, Ma, Us

Boston, Ma, Us

Outsource solutions for all your quality and regulatory needsReilly & Associates, LLC is committed to helping you find the most cost-effective method for achieving quality goals and regulatory compliance. Our role is determined entirely by your needs, and our objective is to dispense efficient and innovative solutions and assistance.By working with you, we can design, implement, and evaluate the systems and documentation necessary to meet US FDA Quality System regulation, ISO 13485, European Medical Device Directives, and Canadian and Australian Medical Device regulations.

Directed departmental activities, including annual budgets and staffing requirementsManaged internal staff and external consultants, including planning, scheduling, and monitoring of work assignmentsSupported business development activities, including generation and implementation of business plansDirected client relations, including client meetings, proposals, ongoing project management and supervisionProject Manager and management representative for internal ISO 9001 programProject Leader assisting a major US / International medical device manufacturer in successfully correcting FDA 483 / Warning Letter deficiencies at multiple facilities world-wide; FDA later lifted consent decree against companyPerformed Quality System audits and assessments for compliance to FDA regulations, ISO and EN Standards, and European Union DirectivesAssisted manufacturers and suppliers in developing, implementing, and maintaining Quality System compliance programs and proceduresAssisted manufacturers and distributors in developing, implementing, and maintaining compliance programs for MDR and recall regulationsConducted GMP requirements and Quality System related training seminarsConducted presentations at public seminars designed to broaden the medical device industry's understanding of compliance and quality system issuesCoordinated Year 2000 program

Initiated a GMP audit program covering 6 separate manufacturing facilities on 3 continentsCoordinator and team leader for company wide ISO 9000 implementation programDeveloped supplier auditing, selection, and maintenance activitiesProvided QA support to R&D and manufacturing, including Validation and Design ControlEstablished and coordinated Quality Policies and GMP manualEstablished centralized documentation control departmentServed as educator for GMPs and Quality Practices

Bethlehem, Pa, Us

Full OEM reliability engineering, from specification generation to first full lot approvalAssisted in developing plant wide process control and validation program utilizing SPC and SQCResponsible for developing and implementing complaint and MDR reporting policies

Bs, Chemical Engineering

Education record