Quality Assurance Specialist II

Job Description

About Cooper Surgical

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. As a division of Cooper Companies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values - dedicated, innovative, friendly, partners, and do the right thing - our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women's and family care, and beyond.

We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at

Work location: Houston, TX (on-site). This is a contract only role for 9-12+ months

Scope:

The Quality Assurance Specialist II reports to the Life Science Quality Manager/ Director. The role will maintain and develop Quality procedure(s), review and approve production lots for release, generate and analyze data for tracking and trending, and work with stakeholders to provide continuous improvement. The Specialist II will be responsible for training the organization on Quality System(s), Quality procedures, and mentoring less experienced team members.

The individual will help drive change to prevent and remediate the risks to internal and external customers.

Job Summary:

The Quality Assurance Specialist II is primarily responsible for establishing, developing, implementing, maintaining, and improving Quality System processes and programs. These include Risk Management, Production Lot Release, Process Monitoring, Quality Event Reporting (Deviations, Nonconformance, Change Management, CAPA, Complaint), Document Control Program, Supplier Qualification, and Validations. In this role, the candidate will train other personnel on the Quality System(s). The Quality Specialist II will partner with stakeholders to improve the quality program and quality culture within the organization.

The candidate should have strong written and verbal communication skills to foster cross-functional collaboration and partnerships, lead by positive influence, maintain a high level of integrity, and possess a strong continuous improvement mindset.

Responsibilities

• Provide Quality oversight, support, and engagement as needed by Operations
• Continuously observe processes and gather data for monitoring
• Identify performance metrics based on direct observation, trending, and quality events
• Coordinate reviews to gather input from various contributing departments.
• Track, trend, and report Quality System metrics to ensure continuous quality improvements while communicating quality and compliance risks.
• Maintains a culture of quality awareness, teamwork, and cooperation with Quality customers.
• Performs and/or facilitates 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 processes and procedural consistency for quality systems records.
• Create and implement a training program for the QMS processes to educate Quality Assurance customers.
• Perform other duties and tasks as directed.
• Owner of Quality Management Processes such as:

☒ Review records from production, inspection, and testing processes for accuracy and completeness to assure compliance with all relevant specifications, procedures, and policies. Certify the quality of acceptable analyses and conformance.

☒ Document Control Program: review, approval, and maintenance of company Standard Operating Procedures via electronic Document Quality Management System. Ensuring stakeholders are adhering to company policies and templates.

☒ Change Management Program:
Review, approve, and track changes to processes, procedures, qualifications, validations, and equipment. Execute, track, and verify action items within a cross-functional team to implement controlled changes.

☒ Deviations and Nonconformances:
Document,…