Quality Engineer II

Forj Medical • Arden Hills, MN

1d

About The Position

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.

Requirements

• Bachelor's degree in engineering or related field or equivalent 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.
• 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
• Must be authorized to work in the United States.

Nice To Haves

• Advanced degree preferred.
• Prefer ASQ, CQE certification.

Responsibilities

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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level