Design Quality Engineer

Job Description

Job Purpose and primary objectives:
 

To provide Design Quality Support and lead relevant activities
 

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:
 

• Collaborate with other functional groups in support of new product development projects
   
• Develop and establish effective quality control and associated risk management plans
   
• Write, review and/or approve process and product validation protocols and reports, equipment qualifications, engineering change orders.
   
• Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE)
   
• Direct Failure Mode and Effects Analysis activities for both Design and Process FMEA's
   
• Determine sterility, biological and packaging test requirements utilizing appropriate industry or agency standards for new products
   
• Ensure that development activities follow design control requirements, product is tested per applicable standards, European Essential Requirements are met per the MDD, and product is properly transferred to manufacturing
   
• Provide all planning necessary to ensure effective product acceptance. This includes, but is not limited to, inspection instructions, equipment and gage requirements, and sampling plans.
   
• Support closure of Corrective and Preventative Actions (CAPA) and Non-Conformances (NC)
   
• Support production floor activities (IQ/OQ/PQ) and product quality investigations
   
• Assist in complaint analysis as appropriate
   
• Assist Regulatory Affairs in developing submissions for new devices as necessary.
   
• Participate in design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes
   
• Recommend issue resolution to senior management for significant capability and compliance issues
   
• Plans, develops, coordinates, and directs one or more large important engineering project or a number of small projects with many complex features.
   
• Carries out complex or novel assignments requiring the development of new or improved techniques or procedures
   
• Develop and evaluate plans and criteria for a variety of projects and activities to be carried out by others
   
• Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment when necessary data are insufficient or confirmation by testing is advisable
   
• 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
   
• American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is desirable
   
• 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.
   
• Knowledge of Quality and operations systems and processes, including GMP and QSR requirements for medical devices
   
• Knowledge of leading-edge Quality Engineering, design control, and verification and validation (V&V) tools and methodologies
   
• 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 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
   
• Proven experience as QA, in Quality Systems or regulatory experience in the medical industry is a prerequisite
   
• Auditor certification from an industry recognized organization is preferable.
   
• Experience in preparation for notified body and FDA inspections