Principal Quality Engineer

Principal Quality Engineer at Pride Health Principal Quality Engineer at Pride Health in Fayville, Massachusetts Posted in 1 day ago.

Type:

full-time

Job Description:

Pride Health is hiring a Full-Time Principal Quality Engineer

• Hybrid to support our client's medical facility based in Marlborough, MA 01752.

This is a 12-month assignment (Possibility of extension or conversion) opportunity and a great way to start working with a top-tier healthcare organisation!

Work Location:

Marlborough, MA 01752

Job Title:

Professional

• Principal Quality Engineer
• Hybrid (3, 4 Days onsite)

Job Duration:

12Months (Possible of extension) Pay is: $60/hr on W2

• Required 8 years' experience (must) Let me know if interested in applying?

Shift/Time Zone:

1st shift

M-F 8-5 EST

(normal business hours Onsite for the 1st 90days) Then Hybrid

• Onsite Monday
• Thursday and Remote on Friday The top skills they are specifically looking for are: Design Control experience IVD / diagnostic industry experience Requirements from client end: Experience in Medical Devices design and development, with a strong focus on design control and risk management is preferred There is potential for this to turn into a direct role with Quest.

Candidates must be open to the idea of the idea of temp to perm, pending the business needs. Please ensure the team understands they need to send us individuals who have worked within Quality/Regulatory Affairs function and understand/have experience as discussed.

Job Description:

Staff Quality Engineer

• Pharma and Diagnostics Job Summary This role ensures that Quest Diagnostics' IVD products meet stringent regulatory requirements and quality standards. The Staff Quality Engineer will lead quality engineering initiatives, support product development and manufacturing processes, and drive continuous improvement in the quality management system. Key Responsibilities
• Develop, implement and maintain quality systems and processes in compliance with FDA CFR Part 820, ISO 13485, IVDR 2017/746, ISO 14971 and other regulations, as appropriate, for IVD products
• Conduct hazard analysis and risk assessments for IVD products according to

ISO14971

throughout the IVD product lifecycle

• Lead internal and external audits, including preparation, execution, and follow-up to ensure adherence to quality and client standards and regulatory requirements
• Oversee corrective and preventive action (CAPA) processes, non-conformance investigations and deviations to resolve quality issues
• Collaborate with cross-functional product development teams to integrate quality requirements into product design, verification and validation activities according to Design Controls
• Review and approve design control documentation including design inputs, design outputs, verification/validation protocols and reports, and risk management documentation.
• Assess and qualify new suppliers in product development and throughout the product lifecycle.
• Establish and maintain Design History File for IVD products
• Establish, monitor and analyze quality metrics, trends and performance data to identify areas of improvement
• Support regulatory submissions and activities for IVD product approvals
• Support complaints process (review, process, investigate, trend quality data, etc.) and post-market incident activities.
• Support post-market incident activities
• Manage post-market incident activities (field action, MDRs, EU incident decision/reporting, field failure trending).
• Maintain knowledge of laboratory regulatory requirements, including accrediting bodies, federal, state, and local requirements as well as Quest Diagnostics policies.
• Drive continuous improvement initiatives in design control and risk management processes, leveraging industry best practices, lessons learned, and feedback from audits and post-market surveillance data
• Stay current with evolving regulatory requirements, standards, and industry trends
• Proactively update internal processes, policies and procedures, and training materials as needed
• Drive continuous improvement initiatives in design control and risk management processes, leveraging industry best practices, lessons learned, and feedback from audits and post-market surveillance data
• Stay current with evolving regulatory requirements, standards, and industry trends
• Proactively update internal processes, policies and procedures, and training materials as needed
• Follow corporate policies and procedures
• Perform other duties as assigned.

Qualifications Required Work Experience:

8+ years of experience in Medical Devices design and development with a strong focus on design control and risk management

Preferred Work Experience:

Experience in working effectively in an FDA-regulated environment Experience working with IVD products Analytical mindset with attention to detail and a commitment to integrity, product safety, and Quality Demonstrated Experience applying medical device regulations (e.g.

IEC 62304, FDA 21 CFR

Part 803, 21 CFR Part 806, 21 CFR Part 820, ISO 13485, ISO 14971, IVDR, CAP, and CLIA).

Knowledge:

Experience with quality management system development, Design Controls, and risk management

Skills:

Communication (verbal and written), ability to build and manage an effective team, being able to influence others and drive for results, effective presentation skills, problem solving

Competencies:

• Demonstrate ability to influence and create change
• Strong interpersonal communication skills
• Demonstrate strong writing and composition skills
• Demonstrate success in motivating team members to reach objectives Business Process Skills
• Able to effect Quality Improvement through problem solving skills and knowledge of quality tools
• Able to lead and drive change
• Organization skills
• Project and team management skills
• Analytical and problem-solving skills
• Proficient in Microsoft Word, Excel, and Powerpoint
• Able to function in a matrix organization
• Flexibility to meet continuously changing priorities and challenges
• Requires ability to understand, interpret and apply quality and regulatory requirements.

Work Environment:

• Prolonged sitting at a desk (i.e., operating a computer, telephone use, document review)
• Walking or standing within the office area to operate other office equipment (i.e. printer / fax) or within the laboratory
• Required to wear PPE as appropriate when visiting testing locations
• Must frequently respond to text/email communications and will be required to be aware of ergonomic principles
• May be required to travel by airplane /train or drive long distances
• Ability to follow verbal or written instructions and use effective verbal and written communication Education Bachelor's Degree (Required) in Biology License/Certifications ASQ Certification preferred Regulatory Affairs Certification (RAC) preferred Pride Global offers eligible employee's comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), 401(k•retirement savings, life & disability insurance, an employee assistance program, , legal support, auto ,home insurance, pet insurance, and employee discounts with preferred vendors.

About Pride Health Pride Health is Pride Global's healthcare staffing branch, providing recruitment solutions for healthcare professionals and the industry at large since 2010. As a minority-owned business that delivers exceptional service to its clients and candidates by capitalizing on diverse recruiting, account management, and staffing backgrounds, Pride Health's expert team provides tailored and swift sourcing solutions to help connect healthcare talent with their dream jobs. Our personalized approach within the industry shines through as we continue cultivating honest and open relationships with our network of healthcare professionals, creating an unparalleled environment of trust and loyalty. Equal Employment Opportunity Statement As a certified minority-owned business, Pride Global and its affiliates

• including Russell Tobin, Pride Health, and Pride Now
• are committed to creating a diverse environment and are proud to be an equal opportunity employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or other characteristics.