Senior Quality Systems Engineer
$93k - $116kExpress Employment Professionals Defunct
Job Full Description We are seeking an Experienced Senior Quality Systems Engineer to join our client's team as a key member of the Quality Systems department. Work schedule: (M-F) 8am - 5pm
Pay rate range: $93,000 -$116,000/year
Job Requirements
2982
129 Morgan Drive
Suite 102
Norwood, MA 02062
Pay rate range: $93,000 -$116,000/year
Job Requirements
- Bachelor's degree (or equivalent) in Engineering, Science, Quality or a related discipline.
- A minimum of 5 years of related experience with a Bachelor's degree; or 3 years and a Master's degree; or a PhD without experience.
- Additional qualification in Quality Assurance or a related discipline is preferred.
- ISO 13485 Auditor training and/or Lead Auditor qualification is preferred.
- Prioritise and manage workload to ensure critical Quality System activities are delivered on time
- Escalate compliance risks and resource constraints appropriately
- Support broader Quality or site activities where required, provided core Quality Systems responsibilities are not impacted
- Strong working knowledge of ISO13485 and applicable regulatory requirements.
- Experience in CAPA, internal auditing, customer complaints and audit support, including leading audits and supporting external inspections.
- Proven ability to lead investigations and drive timely resolution of quality issues, including root cause analysis and follow-up actions.
- Experience working with electronic Quality Management Systems (eQMS), including data management, tracking and reporting of Quality Systems activities.
- Experience working cross-functionally and influencing stakeholders across Quality and Operations.
- Strong problem-solving, organizational and communication skills, with the ability to work independently, manage priorities and escalate risks appropriately.
2982
129 Morgan Drive
Suite 102
Norwood, MA 02062
Vacancy posted 3 days ago
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