Highlight your quality management systems expertise

Emphasize your knowledge of key quality management systems used in the industry, such as:

• Expertise in cGMP, FDA 21 CFR Part 11, ISO 9001, and ISO 13485 quality standards
• 6+ years of experience maintaining quality systems compliant with ISO 9001, ISO 13485, FDA QSR, and MDD requirements

Avoid simply listing the systems without context, like this:

• Familiar with cGMP, ISO 9001, ISO 13485

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   Quantify your impact on quality metrics

Provide specific examples of how you improved quality metrics and compliance, with numbers:

• Reduced customer complaints by 35% through implementing enhanced quality control processes
• Achieved 99.7% compliance rate in internal and external audits of quality management system
• Decreased non-conformances by 28% year-over-year by driving root cause analysis and corrective actions

Don't use vague statements without measurable impact, such as:

• Improved quality and compliance
• Responsible for reducing customer complaints

   Show your cross-functional collaboration skills

Quality compliance coordinators work closely with teams across the organization. Highlight your ability to partner with different functions:

• Collaborated with R&D, manufacturing, and supply chain to integrate quality processes across product lifecycle
• Partnered with global teams to harmonize quality systems across 5 manufacturing sites in North America, Europe and Asia

Skip generic phrases that don't demonstrate cross-functional experience:

• Strong teamwork skills
• Able to work with different departments

   Feature your audit and inspection success

Passing audits and inspections is a key part of a quality compliance coordinator's job. Showcase your track record:

• Managed 10+ successful ISO 9001 and ISO 13485 certification audits with zero major findings
• Led team that achieved 100% compliance in FDA and notified body inspections over 5 years

Steer clear of broad claims without specifics:

• Experienced in preparing for audits and inspections

Use a resume summary to highlight your top audit achievements, like this:

Quality Compliance Coordinator with 7 years of experience maintaining and improving quality management systems. Proven track record of zero FDA 483 observations and warning letters at last 3 employers. Specialize in cGMP, FDA QSR, and ISO 13485 requirements.

   Include your quality certifications and training

List relevant certifications to show your quality compliance expertise, such as:

• ASQ Certified Quality Auditor (CQA)
• Certified ISO 9001 Lead Auditor
• ASQ Certified Quality Engineer (CQE)

Also include any specialized training you've completed:

• Completed AAMI Quality Management Systems and ISO 13485 Course
• Participated in ASQ Failure Mode and Effects Analysis (FMEA) Training

Leave out basic training or certifications not directly related to quality compliance.

   Tailor your resume to the job description

Align your resume with the specific requirements of each quality compliance coordinator job you apply to:

• Carefully review the job posting and note the key skills, experience, and qualifications required
• Prioritize featuring your matching qualifications in your resume summary, skills, and experience sections
• Use similar language as the job description, such as specific quality standards, to show you're a strong fit

Here's an example of a tailored resume summary:

Quality Compliance Coordinator with 5+ years of experience in the medical device industry. Proven track record of maintaining quality systems compliant with FDA QSR, ISO 13485, and MDD requirements. Six Sigma Green Belt experienced in leading CAPA and quality improvement initiatives.

Avoid using the same generic resume for every application, which is less likely to pass applicant tracking systems (ATS) and catch the hiring manager's attention.