Staff Quality Engineer- Pharma and Diagnostics

Job Description:

• This role ensures that 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.

• 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 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

• Bachelor's Degree (Required)

• ASQ Certification preferred

• Regulatory Affairs Certification (RAC) preferred

• Experience in Medical Devices design and development with a strong focus on design control and risk management is preferred

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

• 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).

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

• 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

• 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

• 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.

• Shift/Time Zone: 1st shift M-F 8-5 EST(normal business hours Onsite for the 1st 90days Than Hybrid - Onsite Monday - Thursday and Remote on Friday

Benefits:

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first of the month following at least 1 calendar year after employment begins.

Synectics is an equal opportunity employer.