Job Description
Quality Engineer
We are seeking a Quality Engineer to support a growing medical device environment with multiple upcoming openings. This person will be a well-rounded, hands-on self-starter who is comfortable wearing multiple hats in a smaller-company setting and working across supplier quality, sterilization, and general quality engineering activities.
The ideal candidate will bring experience supporting sterilization processes such as EtO / EO or Gamma, along with a solid background in supplier quality, including supplier audits, supplier issue resolution, and cross-functional quality support. This role is best suited for someone who can operate independently, adapt quickly, and contribute across a broad range of quality responsibilities.
Key Responsibilities:
- Support day-to-day quality engineering activities in a regulated medical device environment
- Work with suppliers on quality issues, audits, and corrective actions
- Assist with supplier quality activities, including qualification, monitoring, and issue resolution
- Support sterilization-related quality efforts, including EtO / EO or Gamma processes
- Partner cross-functionally with operations, manufacturing, engineering, and quality teams
- Contribute to investigations, nonconformances, CAPAs, and continuous improvement efforts
- Help maintain compliance with quality system requirements and internal procedures
Preferred Background:
- Quality Engineering experience in medical device or other regulated manufacturing environments
- Experience with sterilization methods such as EtO / EO and/or Gamma
- Experience in supplier quality, supplier audits, and supplier issue resolution
- Comfortable in a fast-paced environment where flexibility and initiative are important
- Prior experience in a smaller company environment is highly preferred
- Strong communication skills and ability to work across multiple functions