Quality Engineer

3 weeks ago

Pittsfield, United States Puritan Medical Products LP Full time $65,000 - $73,000
Job DescriptionJob Description


Job Summary: The Quality Engineer will oversee the continual improvement of medical devices as well as participate in the design and manufacturing of new devices. Responsibilities as a medical device quality engineer relate to all aspects of the product life cycle, from prototyping to the supply chain to production.

Duties/Responsibilities:

• Develops, implements, maintains and reviews procedures and specifications to implement in the quality assurance program as required by standards and regulations as well as current Good Manufacturing Practices (cGMP).

• Ensures products meet Puritan’s standards and customers quality and product requirements.

• Supports product development or operations team by providing analysis and expertise throughout the inspection process as well as recommendations for improvements.

• Serves as CAPA Coordinator, facilitates identification of root causes of problems in the production process and recommends and/or implements corrective measures.

• Recognizes adverse trends and decides when corrective actions need to be initiated.

• Prepares reports on non-conformances, customer complaints, deviation reports, CAPAs and supplier corrective action reports to track root causes and corrective actions.

• Develops, reviews and evaluates production trend analysis data for presentation at management review..

• Ensure compliance to regulations, ISO 13485, including cGMP.

• Interfaces with internal teams and external parties to increase customer satisfaction by improving the quality of the products from identified quality issues and customer complaints.

• Ensure that all deviations to protocols and/or deviations to acceptance criteria are adequately justified, documented and fully addressed.

• Remains current on regulation changes and ensure all other functions and quality systems are up-to-date with regulatory requirements and guidelines.

• Performs other related duties as assigned.

Required Skills/Abilities:

• Excellent verbal and written communication skills.

• Excellent organizational skills and attention to detail.

• Extensive knowledge of or the ability to quickly learn the organizations production processes.

• Excellent interpersonal skills with the ability to serve as a liaison with developers, project managers, and customer support.

• Strong analytical and problem-solving skills.

• Excellent mathematical skills.

• Proficient with Microsoft Office Suite or related software.

Education and Experience:

• Bachelor’s degree in engineering or related discipline required.

• Prior experience working in a manufacturing environment; Medical Device or highly regulated industry.

• Quality Assurance experience and demonstrated use of Quality tools/methodologies required.

• Strong experience operating within the requirements of ISO 13485, FDA 21 CFR 820, GAMP, GMP and other applicable regulations.

• 6S certification is a plus.

Physical Requirements:

• Prolonged periods sitting at a desk and working on a computer.

• Must be able to lift 15 pounds at a time.

Note: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Work requires operation of a computer.


Monday-Friday
First Shift

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