Senior Quality Assurance Specialist

Key Responsibilities

• Ensure documents are created and maintained according to QMS procedures
• Review and approve procedures and records
• Provide support to create procedures and records
• Ensure changes are requested and executed according to QMS procedures
• Link BOM’s, routers, inspection sheets into SAP and ensure they are correct and complete
• Track status of ECOs and associated documents within the Document Management System (SAP DMS)
• Verify Change Requests prior to approval, including verifying that all required documentation is provided and defined actions are performed
• Support / perform supplier audits
• Support the Senior Quality Assurance Manager in the preparation of internal and external audits (QMS and MAPPS audits)
• Support the Senior Quality Assurance Manager in any follow-up actions resulting from audits (eg. CAPA).
• Perform additional tasks as requested by the manager.

Qualifications

• 2+ years of related experience in a regulated industry; preferably in MedTech/Pharma
• ERP experience; SAP is a plus
• Knowledge MS Office applications, Word, Excel, Outlook
• Specifically extended knowledge of MS Word
• Knowledge of Document Management Systems / Record keeping / Good Documentation Practice
• Knowledge of ISO 13485 and 21 CFR 820
• Good administrative and communication skills
• Good organizational skills
• Fluent in speaking and writing English is required
• Accurate and detailed oriented in the day-to-day job

Critical Success Factors

• Mastery of Regulatory Compliance
• Process Accuracy and Data Integrity
• Proactive Problem Solving and Continuous Improvement
• Effective Collaboration and Communication

Salary Range

Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs.

The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled.

The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans.

$80,600 - $98,500