Job description

Exciting opportunity for a growing Medical Device Manufacturer with room for advancement. They are seeking a candidate with experience in quality engineering, or in a regulated industry, with excellent interpersonal skills and understanding of product safety requirements.

Key Responsibilities

• Identify corrective actions and ensure closure in accordance with company guidelines and external regulatory requirements.
• Responsible for quality engineering review and approval of Engineering drawings and specifications.
• Develop sampling plans by applying attribute, variable, and sequential sampling methods.
• Establish product statistical confidence by identifying sample size and acceptable error, determining levels of confidence.
• Responsible for the track, trend, and review of all quality system events
• Review equipment and process validations to ensure compliance and assess the impact on product reliability and compliance status.

Requirements:

• Professional certifications and Application requirements (ISO 13485 and 21 CFR 820)
• Strong skills in technical writing, project management, communication, statistical knowledge, and problem-solving
• Bachelor’s degree in quality or engineering
• 4+ years of experience in Related industry
• Microsoft office proficiency

Job Type: Full-time

Pay: $75,000.00 - $80,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Supplemental pay types:

• Bonus pay

Work Location: In person

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