Quality Control Engineer — Impactful Med Device QC (Flexible)

Rhythmlink; Columbia, Northern (SC, KY); Hybrid; USD 75,000 - 90,000; Full time

Job summary

Rhythmlink in Columbia, SC is seeking a Quality Control Engineer to elevate our global medical device quality programs. You will own risk management per ISO 14971, oversee supplier quality performance, and lead investigations for CAPAs and non-conformances, helping ensure compliance with ISO 13485 and 21 CFR 820.

Join a team that values rigorous analysis, cross-functional collaboration, and continuous improvement.

Qualifications

• Experience with medical device standards (ISO 13485 & 21 CFR 820)
• Strong problem-solving skills, with a passion for systems, data, and results
• Bonus points for certifications like CQE, CRE, PMP, or Lean Six Sigma

Responsibilities

• Own risk management processes per ISO 14971
• Oversee supplier quality performance and validation activities
• Lead technical investigations for CAPAs and non-conformances
• Review labeling, design controls, and sterilization documentation
• Participate in audits and ensure compliance across global markets
• Flexible work environment
• Work with proven products in a purpose-driven industry
• Join a company with a proven track record of quality and employee satisfaction

Skills

Quality control

Risk management

Regulatory compliance

Problem solving

Job description

Rhythmlink in Columbia, SC is seeking a Quality Control Engineer to elevate our global medical device quality programs. You will own risk management per ISO 14971, oversee supplier quality performance, and lead investigations for CAPAs and non-conformances, helping ensure compliance with ISO 13485 and 21 CFR 820.

Join a team that values rigorous analysis, cross-functional collaboration, and continuous improvement.