Job Description

Job Title: Quality Specialist

Location: Doylestown, PA (on-site, cannot offer relocation)

A local, global, growing medical device company is seeking their next Quality hire to join their team! They are a leader in ophthalmic surgical equipment and have very exciting plans for the next few years - there will be lots of training offered, so it is a great opportunity to join a growing company and grow in your career!

Position Overview:

The Quality Specialist will play a key role in ensuring the effectiveness of our Quality Management System (QMS). This individual will be responsible for CAPA management, supplier quality oversight, and internal and external audit support. The ideal candidate thrives in a fast-paced environment, demonstrates strong problem-solving abilities, and has a solid understanding of regulatory requirements in the medical device industry (e.g., FDA, ISO 13485).

Key Responsibilities:

• Lead and manage Corrective and Preventive Actions (CAPA), ensuring timely investigation, root cause analysis, and implementation of effective corrective actions.
• Support supplier quality activities including supplier qualification, performance monitoring, and resolution of supplier-related quality issues.
• Act as a key contributor in audit preparation, hosting external audits (FDA, ISO, customer), and coordinating timely, thorough audit responses.
• Collaborate cross-functionally to drive continuous improvement and ensure compliance with applicable quality standards and regulations.
• Maintain documentation and records in accordance with regulatory and company requirements.
• Assist in training personnel on quality system procedures and best practices.

Qualifications:

• Bachelor's degree in Life Sciences, Engineering, or related field.
• 3+ years of experience in a Quality Assurance role within the medical device industry.
• Working knowledge of FDA regulations, ISO 13485, and other relevant standards.
• Strong organizational and communication skills.
• Detail-oriented with the ability to manage multiple priorities effectively.

If this sounds of interest, please don't hesitate to apply!

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