Senior Quality Engineer

Exceptional People. Hard Problems. Meaningful Careers. Big Impact.

Nowhere else can you touch as many life-changing medical technologies. At Forj Medical, we work side by side with more than 100 medical device companies from startups to global giants to bring life-enhancing technologies to market. Working with us means solving hard problems with extraordinary people in a collaborative work environment. Join us.

Job Summary:

Senior Quality Engineer supports the organization in manufacturing Class I, II, III (or equivalent) medical device components and finished devices. This role supports our quality system processes, corporate quality initiatives, improvement activities, department strategy and customer quality relationships.

This role is part of the tactical and production line facing portion of the operations quality team and supports both the New Product Introduction (NPI) and commercial sides of the business. Routine activities include enabling production line compliance to quality system processes, implementation of corrective or continuous improvement actions, and execution of technical and strategic projects. You will play a critical role in incorporating quality into processes and ensuring alignment of the production floor to quality initiatives to better serve our patients and customers worldwide!

Job Duties and Responsibilities:

• Be a consistent positive influence on team culture as a role model for high-quality work, effective communication, resilience and solution-oriented thinking.
• Evaluate processes using systems-thinking principles to drive process improvement opportunities, mitigate risk and enhance quality system effectiveness.
• Provide frequent feedback, gap assessment, improvement opportunities, and brainstorming ideas to management to develop short-term and long-term department strategies.

• Train, mentor, and provide technical guidance to the operations quality and peer teams.

• Author, consult, and approve product and system quality related content to ensure risk-based evaluation of Engineering Change Orders, CAPAs, Nonconformances, and deviation requests.

• Lead complex quality investigations, CAPAs, and nonconformances, including root cause analysis, corrective action implementation, effectiveness verification, and risk assessment.

• Collaborate across the organization to ensure clear, effective, and consistent documentation practices are utilized within production and development processes.

• Serve as the Quality point of contact with customer organizations.

• Perform product and/or process validation and verification activities generating and reviewing related plans and reports consistent with company policies and procedures.

• Define, monitor, analyze, and escalate on metrics and KPIs and report out to company leadership.

• Support internal and external quality audits, as required.

Required Qualifications:

• Bachelor’s degree in engineering, technical, scientific, or equivalent discipline

• 7+ years in a regulated manufacturing environment

• Demonstrated experience with regulated environments such as FDA QMSR, ISO13485, and similar

• Effective communication skills to provide technical feedback internally and clear guidance and updates to external customers.

• Ability to evaluate risk and impact of changes and non-conforming conditions and make data driven decisions.

• Ability to work independently, cross functional as a team member, and lead small teams.

• Passionate for change and continuous improvement and embodying a strong sense of urgency.

Preferred Qualifications:

• CDMO experience

• Proficient knowledge of quality improvement tools and techniques.

• Training in Lean Six Sigma

• Minitab or other statistical process control software

• Certified Quality Engineer, Quality Auditor, or similar

• High proficiency in use of standard electronic business tools: Outlook, Word, PowerPoint, Excel, Visio.