Quality Engineer

Defibtech is seeking a Quality Engineer based at our manufacturing site in Branford, CT, responsible for supporting product and process quality for a medical device company in support of class III devices in a cGMP environment. The Quality Engineer will partner cross-functionally to implement quality engineering initiatives supporting manufacturing and supplier activities across all product lines in support of Defibtech’s mission to provide high-quality medical devices.

Core Responsibilities:

• Applies knowledge of statistical process control principles and quality engineering techniques to positively influence manufacturing processes for current and future products.
• Performs data trending for Defibtech (Nonconforming material reports) to identify potential CAPA/SCAR’s from nonconformance trending.
• Supports in production investigations as it pertains to nonconformances, potential supplier issues, design issues, including risk assessment and potential for fielded product impact.
• Represents the Quality function in various roles such as supplier quality, supplier audits, and supplier Quality Agreements.
• Interfaces with Suppliers as needed to monitor process controls and metrics for continuous improvement opportunities, trending potential defects, and product changes.
• Provides quality input in assisting with generating Process Qualification plans, reviewing process inputs, outputs, verification, validation, phase reviews and/or scale up strategies.
• Supports employees in understanding applicable Quality Engineering methodologies and Quality System Processes relating to Quality Engineering.
• Supports review Incoming Inspection drawings and inspection forms, First Article Inspections (FAIs) for new and existing components.
• Assists in the development and maintenance of company procedures for process control, process validation and related areas of the quality management system.
• Supports internal and external audits.
• Demonstrates Defibtech’s values on the job by focusing actions on Integrity, Passion, Ownership, and Innovation. Promotes and participates in continuous improvement.
• Actively supports compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including but not limited to FDA, Quality Systems Regulations, safety regulations and applicable statutes).

Qualifications / Requirements:

• Bachelor’s Degree with at least 2 years of related work experience or the equivalent combination of education, experience, and/or training.
• Preferred candidates will have a bachelor’s degree in an engineering discipline and 3 years of experience.
• A minimum of 2 years in quality within the medical device industry is required.
• ASQ (e.g., CQE, CMQ/OE, etc.) and/or Lean and/or Six Sigma certification is highly preferred.

Knowledge, Skills & Abilities:

• Knowledge of FDA Regulations.
• Knowledge of risk management, including key terms and definitions, assessment tools, and reporting.
• Technical knowledge of medical device process qualifications.
• 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.
• Meticulous with strong analytical and critical thinking skills.
• Demonstrated ability to lead others within small projects or investigational environments.
• Excellent organizational skills and the ability manage responsibilities in a fast-paced environment
• Proficient with Microsoft Office Suite or related software.

Work Environment and Physical Demands:

• Work is primarily based in an office setting and frequently supporting light manufacturing setting.
• Physical demands are primarily sedentary with frequent sitting at a desk working on a computer, standing and short durations of walking throughout location(s) and lifting to 10lbs.

Compensation and Benefits:

• Defibtech offers competitive salaries and a comprehensive benefits package including core health benefits, company-paid disability, and a company matching 401k plan.
• Defibtech promotes a challenging, collaborative, and friendly culture that is centered around our values: Passion, Innovation, Integrity, and Ownership.
• Defibtech is supportive of work balance providing company gatherings to add fun and generous paid time off and flexibility for employees to manage time and responsibilities.
• Defibtech is committed to empowering and supporting our employees in their philanthropic efforts through donation programs and time off for volunteerism.

Defibtech is committed to a diverse workplace and is an Equal Opportunity/Affirmative Action employer and E-Verify Company. 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.

The above description of core responsibilities and qualifications are intended to describe the general nature and level of the work being performed, but they are not an exhaustive list of all the required responsibilities and skills of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Defibtech endeavors to make www.defibtech.com accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact Human Resources at 203.453.6654. This contact information is for accommodation requests only and should not be used to inquire about the status of applications.

NO AGENCY RECRUITERS PLEASE