Quality Assurance Specialist II

Quality Assurance Specialist II

Cooper Surgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life.
Work location: Houston, TX (on‑site). This is a contract‑only role for 9–12+ months.

The Quality Assurance Specialist II is primarily responsible for establishing, developing, implementing, maintaining, and improving Quality System processes and programs, including Risk Management, Production Lot Release, Process Monitoring, Quality Event Reporting, Document Control, Supplier Qualification, and Validations. The role also involves training personnel on the QMS, partnering with stakeholders to improve quality culture, and driving continuous improvement.

• Provide quality oversight, support, and engagement as needed by Operations.
• Continuously observe processes, gather data for monitoring, and identify performance metrics.
• Coordinate reviews to gather input from contributing departments and track, trend, and report quality system metrics.
• Maintain a culture of quality awareness, teamwork, and cooperation with quality customers.
• Perform and/or facilitate testing for continuous improvement and investigations.
• Provide system visibility, communicate status, and close aging items.
• Work cooperatively in a team environment to maintain cross‑functional and cross‑site process consistency for quality system records.
• Create and implement a training program for the QMS processes to educate quality assurance customers.
• Perform additional duties and tasks as directed.
• Owner of Quality Management Processes
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• Review records from production, inspection, and testing for compliance.
• Document Control Program: review, approve, and maintain SOPs via the electronic Document Quality Management System.
• Change Management Program: review, approve, and track changes to processes, procedures, qualifications, validations, and equipment.
• Deviations and Nonconformances: document, analyze, review, approve, and monitor quality events and deviations.
• Supply/Vendor Management: supplier qualification, reassessment, quality agreements, and score cards.
• Validations: review and approval of equipment, systems, and any design transfer to operations.
• Quality Metrics: collect data, conduct analysis, and report trends for quality indicators.
• Compliance: audit plan and reporting, corrective action review, audit hosting and preparation.

• Understand and apply comprehensive quality principles and maintain current understanding of regulations.
• Knowledge of basic statistics, risk tools, technical writing, and investigation review.

• Proficiency in Microsoft Office (Word, Excel, PowerPoint).
• Proficiency with statistical software such as Minitab, R, or Matlab.
• Knowledge of Master Control or similar eQMS is a plus.

• Familiarity with cell and molecular biology concepts.
• Understanding of biochemical concepts such as pH, stoichiometry, enzymatic catalysis.

• Capable of employing statistical methods for measurement system analysis.
• Experience with analytical instrumentation is preferred.

• Respond effectively to changing conditions and anticipate implications.
• Apply a preventative approach and identify inconsistencies and mistakes.

• Make pragmatic decisions based on multiple factors.
• Make decisions quickly when necessary, using logic to support decisions.
• Apply critical analytical skills to find root causes of issues.

• Attention to detail and identify ways to improve processes.
• Takes responsibility for solving problems and displays eagerness to learn.
• Sets high standards and displays dissatisfaction with substandard activities.

• Interact confidently, read situations, and evaluate likely reactions.
• Collaborate effectively and maintain a positive work attitude that supports teamwork and continuous improvement.

• Focus on important issues, employ a risk‑based approach, and achieve performance targets.

• Handle multiple tasks and competing priorities efficiently.
• Prioritize…