Senior CAPA & Quality Systems Engineer — Medical Devices

Align Technology; Raleigh (NC); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Discounts on Invisalign

Back-up Child/Elder Care

Employee Assistance Program

Flexible Spending Accounts

401k plan with company match

Job summary

A leading medical device company is seeking a Sr. Quality Systems Engineer- CAPA to oversee the CAPA process, ensuring compliance with regulations and fostering product quality. The ideal candidate will have a bachelor's degree and a minimum of 8 years of experience in quality management within the medical device industry, along with expertise in CAPA processes and regulatory standards. This role includes leading investigations, collaborating with teams, and providing training on CAPA best practices. Competitive compensation and benefits will be provided.

Qualifications

• Minimum 8 years of experience, preferably in the medical device industry.
• At least 4 years of direct CAPA experience.
• Experience with ISO13485 & 21 CFR Part 820.

Responsibilities

• Lead the CAPA process including investigation and implementation of actions.
• Collaborate with teams to resolve quality issues.
• Develop and maintain CAPA documentation.

Skills

Quality management

Root cause analysis

Cross-functional collaboration

Regulatory compliance

Training and documentation

Time management

Technical reporting

Education

Bachelor’s degree

Tools

Arena

Job description

A leading medical device company is seeking a Sr. Quality Systems Engineer- CAPA to oversee the CAPA process, ensuring compliance with regulations and fostering product quality. The ideal candidate will have a bachelor's degree and a minimum of 8 years of experience in quality management within the medical device industry, along with expertise in CAPA processes and regulatory standards. This role includes leading investigations, collaborating with teams, and providing training on CAPA best practices. Competitive compensation and benefits will be provided.