Quality Engineer II

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.

Quality Engineer II is a mid-level Quality Assurance Engineer position responsible for ensuring product quality, completing validation/qualification activities with little to no assistance and ensuring customer quality needs are met through cross-departmental collaboration. Quality Engineer II roles have little to no customer facing interactions.

• Plans and conducts the analysis, design, test, and/or integration to assure the quality of assigned product or component.
• Performs engineering reviews of design and production documentation for compliance with stated requirements, including vendor/supplier quality manuals and company quality records.
• Applies statistical process control (SPC) or other appropriate methods for analyzing data to evaluate the current process and process changes, to determine corrective actions if needed.
• Perform product and/or process validation and verification activities; generate/review related plans and reports, consistent with company policies and procedures.
• Assist with Measurement System Analysis for new and existing products.
• Assist with equipment calibration activities as assigned.
• Collaborates with process, production, and manufacturing engineering in disposition of non-conforming material, identifying primary root cause and working/implementing corrective and preventive actions.
• Provides input to solve problems identified during quality assurance activities, prioritizing, communicating, and resolving quality issues using appropriate quality engineering practices.
• Prepares and presents technical and program information to team members and management as requested.
• Collaborates with cross functional team members engaged in quality assurance activities.
• Maintains a working knowledge of government and industry quality assurance codes and standards.
• Reviews assigned customer complaints and SCARs and completes requested investigation and documentation in a timely manner.
• Prepares documents for Engineering Change Orders.
• Other duties may be assigned.

• Education: Bachelor's degree in engineering or related field or equivalent experience. Advanced degree preferred.
• Preferred: ASQ, CQE certification.
• Experience: Minimum of two (2) year experience in medical device industry with bachelor’s degree or Minimum Six (6) years’ experience in medical device field.
• Skills: Manufacturing software, Spreadsheet software, Minitab or other statistical process control software and Microsoft office products, excel, word power point, project.
• Ability to use solid works or other CAD software.
• Working knowledge of design controls and Quality System Regulations.
• Eager to learn and good in execution.
• Strong interpersonal, personal, and communication skills.

Physical demands described here are representative of those that must be met by an employee to successfully perform essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing duties of this Job, employee is regularly required to use hands to finger, handle, or feel. Employee is frequently required to stand;

walk; sit and talk or hear. Employee is occasionally required to reach with hands and arms. Employee must occasionally lift and/or move up to 25 pounds.

Disclaimer:
The above statements are intended to describe the general nature and level of work performed by employees assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

EEO Statement:
Forj Medical provides equal employment opportunities to all employees and…