Quality Engineer – Medical Device / Pharmaceutical Manufacturing
Location: Greenville, SC
Department: Quality
Position Type: Full‑time, Salary / Exempt
Schedule: Monday–Friday, 8am–5pm
Reports To: VP of Commercial Operations
Salary: $90,000 - $100,000
Role Summary
The Quality Engineer plays a key role within the Quality Department, supporting validation programs, change control, quality events, and CAPA processes. This position ensures compliance with customer requirements and regulatory standards (including FDA and ISO 13485) and participates in internal and external audits. The role requires strong analytical skills, attention to detail, and the ability to communicate effectively across teams and with customers.
Key Responsibilities
- Lead and perform validation activities, capability studies, and analysis of validation test results.
- Support and maintain the Master Validation Plan, including equipment and process reviews.
- Develop and execute IQ/OQ/PQ protocols for new equipment and new product introductions.
- Create and route Master Manufacturing Batch Records, including PPE requirements.
- Manage change control for Manufacturing Batch Records.
- Review completed batch records and communicate issues or concerns.
- Support the Corrective and Preventive Action (CAPA) program to ensure timely completion.
- Prepare reports, charts, graphs, tables, and other documentation for review and approval.
- Assist in investigations of quality complaints and out‑of‑specification events.
- Monitor corrective and preventive actions resulting from investigations.
- Participate in internal and customer meetings to provide updates and address questions.
- Represent the company professionally during customer and vendor site visits.
- Perform additional duties as assigned.
Skills & Competencies
Language & Documentation Skills
- Ability to interpret FDA, ISO 13485, EPA regulations, and customer specifications.
- Ability to analyze batch records, audit findings, and technical documentation.
- Strong written communication skills for factual documentation and reporting.
- Ability to present information effectively to management and external stakeholders.
Technical & Computer Skills
- Proficiency in Microsoft Office (Word, Excel, PowerPoint).
- Experience with Minitab preferred.
- Strong understanding of Good Manufacturing Practices (GMP).
- Hands‑on experience with validation of packaging equipment (SAT, IQ/OQ/PQ).
Professional Attributes
- Highly detail‑oriented with strong problem‑solving skills.
- Quick learner with the ability to react effectively to unexpected issues.
- Strong organizational skills and ability to work independently.
- Positive attitude, initiative, and self‑motivation.
- Ability to collaborate effectively within a team environment.
- Sound judgement and ethical decision‑making.
Education & Experience Requirements
- Bachelor’s degree in Engineering preferred.
- 2+ years of experience in a Quality role within an FDA‑regulated Medical Device or Pharmaceutical manufacturing environment.
- Background in Science, Chemistry, or Microbiology is a plus.
- Certifications such as CQE, CQA, Six Sigma, or Lean are preferred.
- Willingness to attend training and skill‑building seminars as needed.
