Senior Quality Engineer

Defibtech, LLC in Guilford, CT

position filled
Defibtech is seeking a Senior Quality Engineer to provide support and leadership across the organization to ensure the successful development of products, by applying their knowledge of Design Control & Quality System principles and quality engineering techniques to positively influence product development efforts throughout the design lifecycle. This position requires a team oriented and hands on individual, partnering directly with design teams from early stages of design in order to plan phase activities, define strategies, mitigate product and business risks, and assure successful execution, transfer and scale up as required.
 
Responsibilities Include:

Demonstrate quality assertiveness and can represent the Quality function in various roles such as product support and lifecycle management, including post market activities.
Apply knowledge of Design Control principles and quality engineering techniques to positively influence new product development efforts, including those for design inputs, specification development, verification, design and process validation, and risk management. 
Provide quality role in assisting with generating Design Plans, reviewing design inputs, outputs, verification, validation and design transfer/scale up strategies.
Support Risk Management activities for new and sustaining engineering projects.
Act as a subject matter expert on the Design Control Process, Quality Systems and Quality Engineering methodologies.
Successfully address complex engineering issues where analysis of situations or data requires an in-depth evaluation of variable factors supporting design and post market requirements, such as CAPAs, audits, complaints and sustaining activities.
Provide guidance to engineering staff and other personnel, and ensure that quality system requirements are being met in an effective manner in order to achieve quality by design, including those for design verification, validation, specification and procedure development, risk management, and design review. Generate plans, draft reports and review reports, as necessary.
Provide input to design and manufacturing engineering project deliverables including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested. Review files for accuracy and completeness and provide guidance on compliance and procedures. 
Assist in the development and maintenance of company procedures for design control, change management, risk management, process validation and related areas of the quality management system.
Represent the design quality assurance department to all auditors/inspectors.
Participate on Core Teams as the design quality representative.
Maintain knowledge of current regulatory requirements and standards as they pertain to the development and marketing of medical devices.
Support post market activities such as complaint investigation, complaint trending, CAPA, and FCA processes

Qualifications/Requirements:

Bachelor’s Degree in a technical discipline and 10+ years of related work experience.
A minimum of 7 years in a Quality Engineering role and experience in the medical device industry is required. 
Knowledge of FDA Regulations and Medical Device Software Development Lifecycle.
ASQ (e.g., CQE, CMQ/OE, etc.) and/or Six Sigma certification highly preferred.
Knowledge of reliability, maintainability, and risk management, including key terms and definitions, systems design, assessment tools, and reporting.
Technical knowledge of medical device verification and validation
Understanding of FDA QSR Part 820, ISO 13485, ISO 14971, EU MDD / EU MDR
Understanding of a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements.
Knowledge of inspection and audit process including types of audits, planning, preparation, execution, reporting results, and follow-up.
Strong interpersonal, communication, influencing, and negotiation skills with the ability to work on teams and individually.
Detail oriented with strong analytical and problem-solving skills.
Demonstrated ability to lead others within small project or investigational environments.
Excellent organizational skills and the ability manage multi-task in a fast-paced environment.

Compensation and Benefits:

Defibtech offers competitive salaries, company bonus plan and a comprehensive benefits package, including a matching 401k plan.
Defibtech promotes a challenging, collaborative, friendly and mature culture in which to work.
Defibtech has a liberal and flexible work environment which allows for latitude and flexibility to manage time and responsibilities.
Defibtech provides perks such as weekly company lunch, a steady supply of fruit, and challenging games of ping-pong!

For review and consideration, please submit resumes to:
jobs@defibtech.com

Defibtech is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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