Development Quality Engineer II

Cynet Systems • Saint Paul, MN

3d

About The Position

The Quality Engineer II assures that products, processes, and quality records conform to quality standards and establishes compliance within the quality system. The role works collaboratively with multifunctional teams to protect patient safety and meet business needs. It includes managing nonconformance and complaint investigations, applying root-cause problem solving, and sharing event information with business partners.

Requirements

• Bachelor-level degree in Engineering, a technical field, or equivalent.
• 2–5 years of technical experience.
• Previous quality assurance or quality engineering experience and use of quality tools and methodologies.
• Strong verbal and written communication skills, including the ability to communicate effectively at multiple organizational levels.
• Advanced computer skills, including statistical and data analysis and report writing.
• Ability to work both within a team and as an individual contributor in a dynamic, changing environment.
• Ability to multitask, prioritize, and meet deadlines in a timely manner.
• Excellent organizational and follow-up skills, and attention to detail.

Nice To Haves

• Advanced degree.
• Detailed knowledge of FDA, GMP, and ISO 13485.
• ASQ CQT, CQE, or CQA certification.
• Six Sigma root-cause analysis or problem-solving training and experience.

Responsibilities

• Follow applicable quality regulations and standards, Environmental, Health, Safety, and Energy (EHS&E) Global Policies, engineering standards, and other governance requirements.
• Implement and maintain the effectiveness of the Quality System.
• Identify compliance risks related to internal and external requirements.
• Complete nonconformance, CAPA, and complaint investigations, and offer multiple solutions with clear advantages and disadvantages.
• Influence key partners to develop and maintain QA procedures, forms, and systems.
• Lead meetings and communications concerning QA system information, concerns, and updates.
• Help drive standard methodologies for data trending, tracking, and identifying manufacturing-related complaints in alignment with goals.
• Follow FDA regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
• Maintain positive and cooperative communications and collaboration with employees at all levels, customers, contractors, and vendors.
• Perform other related duties and responsibilities as assigned.

What This Job Offers

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