Job Responsibilities
- Responsible for compliance with company policies and procedures and applicable International Regulations.
- Leads and/or facilitates compliance and improvement activities associated with the company quality system (e.g., CAPA, audit programs, personnel training).
- Monitor compliance with company policies, procedures, and applicable regulatory requirements, identifying, reporting and implementing process and system improvements.
- Apply thorough, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Plan, execute, report and follow-up on quality system audits. Act as an audit escort and/or support in the coordination of backroom activity during inspections as required.
- Demonstrate an ability to apply, recommend and/or create quality tools and apply them effectively to a variety of business situations related to production, project, and team environments, including contributing towards the generation of risk management file documents.
- Preparation and reporting of data on production, environmental monitoring, vendor assessment, non-conformances, and supplier corrective actions for use in management review.
- Actively participates in and supports departmental activities and responsibilities in accordance with existing procedures and external regulations.
- Tracks and reports progress across projects and departmental commitments by reviewing schedules and due dates, identifying risks, and assisting teams with contingency plans.
- Resolves project issues by working with team members, suppliers, and others as appropriate.
- Assists department and project leaders in developing and reporting appropriate performance and quality metrics.
- Reviews and approves operational, test and validation data to establish conformance to technical specifications and performance standards for existing, new, or modified products and processes, including the review and approval of production records and sterilization records prior to release of product.
- Provides technical quality guidance to team members, technician, and inspection staff.
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
- This is primarily an office-based role, but assignments may require placement in a production/cleanroom environment. The successful candidate must be able to travel (national and international) – approx. 5-10% of role.
- Minimum Bachelor's Degree in Engineering, Science, or related technical field.
- 5 years minimum QA, Quality System, or regulatory experience in the medical industry a prerequisite.
- Auditor certification from an industry recognized organization is beneficial.
- Knowledge of FDA’s 21 CFR Part 820 (Quality System Regulation), ISO 13485:2016, the European Medical Device Directive, and the Canadian Medical Device Regulations.
- Experience in preparation for notified body and FDA inspections.
- Experience in the QA activities associated with a manufacturing environment including project management skills and leadership ability.
- Results and deadline driven with an ability to handle multiple tasks and operate in a fast-paced environment.
- Excellent interpersonal skills and ability to work with people to achieve results.
- Good judgment/decision making and problem-solving ability, capable of understanding the impact of decision making on both company and their customers.
For an immediate interview please forward your CV using the apply button
Or call Megan Warr on 091507515 for a confidential conversation
