What are the responsibilities and job description for the Senior Quality Engineer position at Novozen Healthcare LLC?
Job Title: Sr. Quality Engineer
Location: Palm Beach Gardens, FL (Preferred) / Raynham, MA
Summary:
We are seeking a Senior Quality Engineer with 8–10 years of experience to support quality engineering activities within manufacturing or service/repair environments. This role focuses on quality management systems, validation activities, and cross-functional collaboration while driving compliance with ISO 13485 standards. The ideal candidate will bring strong technical expertise along with leadership and communication skills to support project execution and quality initiatives.
Responsibilities:
- Support and maintain Quality Management System (QMS) processes in compliance with ISO 13485.
- Lead and support equipment and process validation activities (IQ/OQ/PQ).
- Participate in commissioning and qualification activities.
- Collaborate with cross-functional teams including Manufacturing, Engineering, and Quality.
- Drive quality improvements within manufacturing or service/repair operations.
- Provide project management and leadership support for quality initiatives.
- Present and communicate quality-related updates to stakeholders and leadership teams.
Required Qualifications:
- 8–10 years of experience in Quality Engineering.
- Experience in manufacturing or service/repair environments.
- Strong experience with Quality Management Systems (QMS).
- Hands-on experience with equipment validation and process validation.
- Experience with commissioning or qualification activities.
- Project management or leadership experience.
- Strong knowledge of ISO 13485.
- Excellent communication and presentation skills.
Preferred Qualifications:
- Lean Six Sigma Green Belt or Black Belt certification.
- Project Management or ASQ certifications (e.g., CQE, CIA).
- Master’s degree in Engineering or related technical field.