Senior Quality Systems Specialist

About the Role

The Senior Quality Specialist assists in administering quality functions at a site to ensure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR, and other applicable regulatory standards. This role manages document control, site record retention, calibration, and inspection activities, while leading investigations for customer complaints, CAPA, and NCRs. Additionally, the Specialist supports site audit activities, supplier quality, customer assessments, and risk management.

Responsibilities

• Manage the document control processes for the site.
• Lead customer complaint investigations and ensure complete documentation.
• Lead CAPA and NCR investigations and ensure proper documentation.
• Manage the Device History Record (DHR) and batch record release process.
• Oversee record retention practices within the site.
• Coordinate site calibration activities and recordkeeping.
• Manage site audit activities and recordkeeping.
• Support supplier quality and customer assessment activities.
• Track, trend, and analyze quality data.
• Support targeted Lean activities.
• Complete other duties as assigned.

Requirements

• Bachelor’s degree in a related technical field (e.g., Engineering, Chemistry, Biology).
• Minimum five (5) years of experience in a regulated industry (e.g., FDA/ISO 13485).
• Knowledge of standard quality analysis tools (Problem Solving/Root Cause Analysis).
• Proficiency in PC applications, including Excel and Word.
• Ability to take ownership of tasks and projects, seeking clarification when needed.
• Understanding and interpretation of appropriate regulatory standards.
• Ability to analyze and interpret data for problem-solving.

Qualifications (Preferred)

• Certification: ASQ, QSR, or AAMI certification preferred.

Benefits

• Market-competitive pay with shift differential.
• Extensive paid time off and nine (9) additional holidays.
• Comprehensive healthcare, dental, and vision benefits.
• Long/short-term disability coverage.
• 401(k) with company match.
• Maternity and paternity leave.
• Additional benefits/discounts (e.g., pet insurance, tuition reimbursement, continued education programs).
• Opportunities for advancement in a stable, long-term career.

Pay

Pay range for this opportunity is $78,200 – $96,600. This position is eligible for bonus participation. Minimum pay rates offered will comply with county/city minimums, if higher than the range listed. Pay rates are based on factors including local labor market costs, years of relevant experience, education, professional certifications, and foreign language fluency.