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SalaryPharmEng Technology is committed to attracting and retaining world-class employees valued for their contributions to achieving business objectives. At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion, and perseverance are nurtured while serving our clients to achieve their unique business goals. We are seeking an experienced Senior Quality Engineer to join our team.
Role:
The Senior Quality Engineer will oversee and participate in day-to-day Quality Engineering and control activities. They will also lead quality assurance activities and generate reports to drive product quality and performance improvements.
- Ensure all systems and applications are tested and meet functional and non-functional requirements.
- Contribute to the development of new ideas and approaches to improve work processes.
- Submit, maintain, and follow-up through to the resolution, of all reported issues using an established defect control system.
- Help with root cause analysis.
- Interact with SMEs in all functional areas to manage their response to any findings and their timely commitment to address those findings within CAPA and other quality systems.
- Partner with Regulatory to assess new or revised regulations and standards.
- Interface with the clients, auditors and regulatory agents during inspections and meetings to ensure information is provided in a timely, accurate and complete manner.
- Manage the activities under site’s Audit Readiness program including floor walks, document/process gap assessment, Compliance training and coaching in routine cadence to help the site close those compliance gaps, and ensure the site is Regulatory inspection ready at all times.
Qualification:
- Quality Engineering, Quality Control, and Quality Management skills
- Experience in product quality and quality assurance
- Strong analytical and problem-solving skills
- Excellent communication and interpersonal abilities
- Experience with statistical process control methods and tools
- Experience with ISO 9001, ISO 13485, and/or FDA regulations is desirable
- Bachelor's or Master's degree in Engineering or related field
Travel:
Must be willing to travel approximately 10 – 20%
