Spec Quality

About the role

This role specializes in one or two particular subsections of our Quality Management System (e.g. Device Master Records, customer complaint, product hold, recalls, incoming quality). Responsible for building and maintaining quality documentation and processes such as product specifications, manufacturing tolerances, engineering drawings, inspection criteria, testing reports, ERP system analysis, customer complaint analysis, and validations.

Responsibilities

• Assist in the development and implementation of processes, reports, data analysis, and procedures within the defined area of specialization.
• Collaborate with multiple groups (both internal and external) to solve complex problems and ensure compliance with FDA, ISO, and internal requirements.
• Facilitate meetings with global business units, sales, marketing, and branch personnel to manage project requirements and deadlines. Track and report progress periodically to management.
• Review all related documentation and analysis for completeness and accuracy, ensuring the product and reports meet all specifications.
• Make recommendations and decisions based on documentation and analysis to improve quality standards and customer experience.

Requirements

• Bachelor’s degree in Engineering, Science, Math, or other related field.
• At least 2 years of experience in Quality.
• Experience developing ways of accomplishing goals with little or no supervision, determining when to escalate issues.
• Strong time management skills to prioritize, organize, and track details to meet deadlines across multiple projects.
• Proficiency in MS Office Suite (Word, Excel, PowerPoint, Outlook), with intermediate Excel skills.
• Ability to process relevant details, understand their importance, and draw clear, concise conclusions.
• Working knowledge of government and industry quality assurance standards (e.g., 21 CFR 820, ISO 13485).
• Up to 10% travel required.

Pay

Anticipated salary range: $67,000 – $101,000 annually. Actual salary will vary based on location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible.

Benefits

• Health insurance, life and disability coverage.
• 401(k) contributions.
• Paid time off.
• Employee Assistance Program, Employee Resource Groups, and Employee Service Corp (for employees working less than 30 hours per week).

View a comprehensive list of our benefits.