Senior Quality Engineer

Job Description

Job Purpose and primary objectives:
 

To provide quality support in execution of EU MDR transition, QMS deliverables such as packaging and labelling updates and lead all related activities.
Permanent and Contract Options available
 

Key responsibilities
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate procedures and guidelines, the duties and responsibilities for this position are:
 

• Responsible for compliance with Organization Policies and Procedures and applicable International Regulations
   
• Leads and/or facilitates compliance and improvement activities associated with the Organization quality system (e.g. CAPA, audit programs, personnel training).
   
• Monitor compliance with Organization 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; Risk Management Plan, dFMECA, pFMECA and associated reports.
   
• Preparation and reporting of data on production, environmental monitoring, vendor assessment, non-conformances and supplier corrective actions for use in management review.
   
• Represent Organization professionally and positively externally to agencies, vendors and regulators.
   
• Other responsibilities will include (but are not limited to) the following:
   
• Actively participates in and supports departmental activities and responsibilities in accordance with existing procedures and external regulations.
   
• Makes decisions that are aligned with management objectives regarding work processes, plans and schedules in order to achieve quality objectives.
   
• 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.
   
• 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.
   
• Performs other duties assigned as needed.
   
• Responsible for communicating business related issues or opportunities to next management level
   
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
   
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
   
• Performs other duties assigned as needed

Key Skills/Knowledge:

• Experience in QA activities associated with a manufacturing environment including project management skills and leadership ability
   
• 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.
   
• 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.
   
• Excellent written and communication skills, fluency in English.
   
• Good judgment/decision making and problem-solving ability, capable of understanding the impact of decision making on both our client and their customers.
   
• Highly motivated and an enthusiastic self-starter with the ability to work under own initiative and as a team player.
   
• Proficiency in MS office products.
   
• Good business acumen.
   
• Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience
   

Key Skills/Knowledge:

• Experience in QA activities associated with a manufacturing environment including project management skills and leadership ability
   
• 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.
   
• 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.
   
• Excellent written and communication skills, fluency in English.
   
• Good judgment/decision making and problem-solving ability, capable of understanding the impact of decision making on both our client and their customers.
   
• Highly motivated and an enthusiastic self-starter with the ability to work under own initiative and as a team player.
   
• Proficiency in MS office products.
   
• Good business acumen.
   
• Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience
   

Experience required:

• Bachelor's Degree in Engineering, Science or related technical field
   
• Good duration & range of experience in QA, Quality Systems or regulatory experience in the medical industry is a prerequisite
   
• Auditor certification from an industry recognized organization is beneficial.
   
• Experience in preparation for notified body and FDA inspections