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.

Job Summary:

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.

Job Duties and Responsibilities:

1. Plans and conducts the analysis, design, test, and/or integration to assure the quality of assigned product or component. *

1. Performs engineering reviews of design and production documentation for compliance with stated requirements, including vendor/supplier quality manuals and company quality records. *

2. 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. *

3. Perform product and/or process validation and verification activities; generate/review related plans and reports, consistent with company policies and procedures. *

4. Assist with Measurement System Analysis for new and existing products. *

5. Assist with equipment calibration activities as assigned. *

6. Collaborates with process, production, and manufacturing engineering in disposition of non-conforming material, identifying primary root cause and working/implementing corrective and preventive actions. *

7. Provides input to solve problems identified during quality assurance activities, prioritizing, communicating, and resolving quality issues using appropriate quality engineering practices. *

8. Prepares and presents technical and program information to team members and management as requested.

9. Collaborates with cross functional team members engaged in quality assurance activities.

10. Maintains a working knowledge of government and industry quality assurance codes and standards. *

11. Reviews assigned customer complaints and SCARs and completes requested investigation and documentation in a timely manner. *

12. Prepares documents for Engineering Change Orders. *

13. Other duties may be assigned.

14. Essential Functions

Qualifications and Requirements:Education:

• Bachelor's degree in engineering or related field or equivalent experience Advanced degree preferred.
• Prefer 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 Requirements:

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.

All positions are responsible for following applicable company policies and procedures as defined by their manager.

EEO Statement

Forj Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Working Condition

Must be authorized to work in the United States.

Compensation and Total Rewards Package

The salary range for this position is outlined below under "Job Details" and is dependent upon the individual's skills, experience, qualifications, and applicable employment laws. Beyond base salary, Forj offers a competitive Total Rewards Package. We offer health, dental, vision, 401K plans, and time off programs. You may also be eligible to participate in an annual bonus program which depends on various factors, including, individual and organizational performance.