Spec QA

Job Summary

This role specializes in one or two particular subsection(s) of our Quality Management System (e.g. Device Master Records, customer complaint, product hold, recalls, incoming quality). Responsible for basic 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.

Major 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 continue to ensure compliance is maintained with FDA, ISO and internal requirements.
• Facilitate meetings with global business units, sales, marketing, branch personnel to manage project requirements and deadlines. Track and report progress periodically to management.
• Review all related documentation and analysis for completeness, accuracy, and assure the product and reports meets all specifications.
• Make recommendations and decisions based off the documentation and analysis that leads to better quality standards and customer experience.

Minimum Job Requirements

Education

• Typically requires a Bachelor's degree in Engineering, Science, Math or other related field.

Certification / Licensure

• None

Work Experience

• At least 2 years of experience in Quality.

Knowledge / Skills / Abilities

• Experience developing ways of accomplishing goals, with little or no supervision, depending on oneself to complete objectives, and determining when escalation of issues is necessary.
• Experience using time management skills to prioritize, organize, and track details in order to meet deadlines of multiple projects.
• Experience using MS Office Suite products (Word, Excel, PowerPoint, Outlook), with an Intermediate skill in Excel.
• Experience in processing all relevant details, understanding and prioritizing their importance, and drawing clear and concise conclusions.
• Working knowledge of government and industry quality assurance standards (e.g. 21 CFR 820, ISO 13485).
• Position requires up to 10% travel

Preferred Job Requirements

Education

• None

Certification / Licensure

• None

Work Experience

• None

Knowledge / Skills / Abilities

• None

Additional information

Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.

The anticipated salary range for this position

$67,000.00 - $101,000.00 Annual

The actual salary will vary based on applicant's location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.

Pay and benefits

Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please

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