Senior Quality Engineer
On-site · Philadelphia, Pennsylvania, United States
Job Summary
Senior Quality Engineer responsible for QA leadership and regulatory-compliant quality systems across product development and commercialization; leads design controls, risk management, and regulatory alignment (ISO 13485, FDA 21 CFR Part 820/812, MDSAP); maintains Design History File and Device Master Records, participates in audits, and drives continuous improvement in quality processes across cross-functional teams; requires BS in engineering or life sciences and 4-7 years in a medical device or regulated environment; strong communication, organizational, analytical, and leadership skills; proficient with MS Office and QMS procedures.
Required Qualifications
- BS in Engineering or Life Science Field
- 4-7 years of experience in medical device industry or regulated environment (e.g., ISO 13485:2016, 21 CFR Part 820 and MDSAP) in one of the following functions: Quality Assurance/Quality Engineering and Product Development Engineering
- Strong communication and organizational skills
- Intermediate to advanced knowledge of MS Office Suite (e.g., Word, Excel)
- Self-starter with high attention to detail and ability to work on multiple projects
- Demonstrated ability to participate in cross-functional team environment
- Strong written and verbal communication skills
- Ability to work independently with little to no supervision
- Excellent organizational abilities and superior attention to detail
- Must have high level of interpersonal skills
- Possesses strong analytical and problem-solving skills
- Excellent time management skills and project management skills
- Capability of objective analysis
- Proactive attitude to address problems
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.