Job Summary:

The Sr QE is responsible for providing QA leadership and partnering with product development with planning, coordinating, and managing the quality assurance (QA) activities associated with PD projects to ensure compliance to internal and external requirements during the development and commercialization of new products and changes for existing products.

Responsible for providing technical leadership in establishing, implementing, and maintaining quality system processes and documentation in compliance with domestic and international regulatory/quality requirements

Job Responsibilities:

• Design Control Coordinator: works with product development engineering to ensure proper completion of required documentation for design control phases according to the design controls SOP.
• Ensures the electronic Design History File is maintained.
• Represent Quality on product development teams to ensure adherence to company quality procedures and applicable US and OUS regulatory requirements and standards.
• Assure that all applicable elements and product technical standards that are applicable to a design category are effectively incorporated into new designs and into changes to designs.
• Coordinates with Regulatory Affairs and Product Development to identify the full range of standards for all intended regions for distribution.
• Ensure completion of Risk Management activities for new and/or modified products and processes, which include risk assessment, occurs in the appropriate phase of the project, authoring risk management plans and reports, facilitating risk assessment activities with no guidance required.
• Collaborate with risk management team members from regulatory, product development, and medical affairs/clinical to ensure robust and realistic documents are created.
• Author and maintain all risk documentation required for company products.
• Complete design history file verifications at the end of each design control phase.
• Support the creation and maintenance of Device Master Records (Technical Dossier) for all products.
• Review and approve all external Engineering Change Orders provided by the contract manufacturer and assess risk documentation.
• Review and approve all internal change orders and assess risk documentation.
• Assist in writing, updating and/or reviewing of procedures and other quality assurance related technical data forms and quality documents.
• Adhere to QMS requirements outlined in procedures and work instructions.
• Review validation protocols and reports for GMP compliance and alignment with industry best practices.
• Assist in carrying out internal quality audits on company systems and documentation.
• Authors non-conformance reports and initiates and owns corrective actions.
• Perform investigations using recognized quality engineering tools of non-conformance, customer complaints and corrective actions.
• Ensures the timely and effective follow-up of all identified or assigned quality issues.
• Assists in the maintenance of the Quality Management System.
• Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Provide training and support for quality system processes and quality engineering practices to members of the quality group as well as across the organization.
• Maintains and demonstrates understanding of global standards, regulations, and regulatory bodies to include but not limited to ISO 13485:2016, ISO 14971, 21 CFR part 820, 21 CFR part 812, MDSAP and MDR.
• Manage the Post Market Engineering system to identify trends and recommend actions.
• Review every complaint for trends and for linkages to risk management system.
• Perform updates as needed.

Qualifications:

• BS in Engineering or Life Science Field
• 4-7 years of experience in medical device industry or regulated environment (e.g., ISO 13485:2016, 21 CFR Part 820 and MDSAP) in one of the following functions: Quality Assurance/Quality Engineering and Product Development Engineering
• Strong communication and organizational skills.
• Intermediate to advanced knowledge of MS Office Suite (e.g., Word, Excel)
• Self-starter with high attention to detail and ability to work on multiple projects
• Demonstrated ability to participate in cross-functional team environment
• Strong written and verbal communication skills
• Ability to work independently with little to no supervision
• Excellent organizational abilities and superior attention to detail
• Must have high level of interpersonal skills
• Possesses strong analytical and problem-solving skills
• Excellent time management skills and project management skills
• Capability of objective analysis
• Proactive attitude to address problems