Quality Specialist

Brooksource; Mentor (OH); On-site; USD 52,000 - 74,000; Full time

Job summary

Brooksource is seeking an Associate Quality Specialist to administer the site’s quality functions, ensuring compliance with ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and related standards. This role coordinates document control, site record retention, calibration and inspection activities.

You will facilitate customer complaint investigations, support audits, supplier quality, and risk management, and help track quality data for management review purposes.

Qualifications

• High school diploma or GED.
• Minimum 2 years experience in a regulated industry (FDA/ISO 13485).
• Proficiency with desktop apps (Excel, Word) and PC basics.

Responsibilities

• Review customer complaints and complete complaint documentation.
• Facilitate CAPA and NCR investigations and may coordinate investigation documentation.
• Review DHRs and support batch record release.
• Manage record retention practices within the site.
• Manage site calibration activities and recordkeeping.
• Support site inspection activities and recordkeeping.
• Assist in internal and external audits.
• Support supplier quality and Customer assessment activities.
• Track and trend site Quality data.

Skills

Customer Focused

Teamwork

Results

Communication

Attention to detail

Education

High school diploma or GED

Tools

Excel

Word

Job description

As an Associate Quality Specialist, you will be responsible for administering of all site’s quality functions relating to customers and the adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR, and other applicable regulatory standards. This role coordinates document control transactions, site record retention, calibration and inspection activities. In addition, the Quality Specialist will facilitate Customer complaint investigations, assist in audit coordination, support supplier quality and customer assessments, and support risk management activities where appropriate. This role may also track and trend Quality data and support the site Management Review process.

Shift: 5:00 am-3:30 pm Monday-Thursday

What you will do as an Associate Quality Specialist

• Review customer complaints and complete complaint documentation.
• Facilitate CAPA and NCR investigations and may coordinate investigation documentation.
• Review DHRs and support batch record release.
• Manage record retention practices within the site.
• Manage site calibration activities and recordkeeping.
• Support site inspection activities and recordkeeping.
• Assists in internal and external audits.
• Support supplier quality and Customer assessment activities.
• Track and trend site Quality data.
• Support targeted Lean activities.
• Complete other duties as assigned.

The Experience, Skills and Abilities

Required:

• High school graduate/GED
• Two (2) years experience in a regulated industry (i.e. FDA/ISO 13485)

Other:

• Customer Focused: Demonstrates a “Customer first” mindset. Responds with a sense of urgency.
• Teamwork: Collaborates with others. Works in a professional manner to support team actions.
• Results: Effectively manages work tasks. Is detail oriented and strives for continuous improvement. Ability to analyze technical issues. Ability to cope with change and shifting priorities.
• Communication: Constructs clear written communication. Keeps manager and co-workers informed.
• Job Knowledge: PC experience and working familiarity of common desktop applications including Excel and Word.