CooperSurgical · 1 day ago
Quality Assurance Specialist II
Houston, TX
Full-time
Onsite
Mid, Senior Level
6+ years expCooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families. The Quality Assurance Specialist II is responsible for establishing, developing, implementing, maintaining, and improving Quality System processes and programs, while also training personnel and fostering a culture of quality within the organization.
Health CareMedical DeviceWomen's
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, analyze, review, approve, and monitor quality events and deviations. Handle complaints, nonconformances, and CAPA’s. Perform investigation tasks, track activities for record keeping, and facilitate cross-functional efforts to prevent and mitigate risks to internal and external stakeholders
Supply/ Vendor Management: Supplier qualification, reassessment activities, quality agreements, quality score cards. Oversee the process is maintained and approved according to processes
Validations: Review and approval of equipment, systems validation/ qualification, and any design transfer to operations
Quality Metrics: Collect data, conduct analysis, and report trends for quality indicators. Identify quality metrics, risks, and improvements to improve process control
Compliance: Audit plan and reporting to applicable standards. Review and approval of corrective action and supporting evidence. Aid in audit hosting and preparation. Aid in tracking and trending of internal and external findings, investigation and implementation of corrective/ preventive measures
Qualification
Required
Bachelor's degree (BA/BS) from four-year college or university required
Candidates must show knowledge and proficiency in the Quality Assurance Specialist II role
Understand and apply comprehensive knowledge of quality principles and maintain current understanding of regulations
Knowledge and experience with basic statistics, review/approval of documentation; risk tools, technical writing, and writing/reviewing/approving investigations
Demonstrated experience and proficiency in Microsoft Office applications, Word, Excel and PowerPoint
Proficiency with statistical software such as Minitab, R, or Matlab
Knowledge of Master Control, or similar eQMS a plus
Familiarity with cell and molecular biology concepts such as cell structure and DNA replication
Understand biochemical concepts such as pH, stoichiometry, enzymatic catalysis
Capable of employing statistical methods for measurement system analysis
Experience with analytical instrumentation preferred
Responds effectively to changing conditions and constraints
Understands the drivers of change and anticipates the implications of changing circumstances
Applies a preventative instead of corrective approach
Checks information, picks up inconsistencies, identifies mistakes, and can make detailed comparisons between similar sources
Makes pragmatic decisions based on range of factors
Able to make decisions quickly where necessary, based on incomplete information
Demonstrates logic to back up decisions
Excellent critical analytical skills – ability to find the root cause(s) of issues
Attention to detail
Identifies ways to improve processes/situations
Takes responsibility for improvements or solving problems
Must display eagerness to learn and continuously improve
Sets own standards above prevailing standards, shows dissatisfaction with substandard or inefficient activities
Socially capable - interacts confidently, reads the situation
Empathetic and can evaluate likely reactions
Collaborative approach
Positive work attitude that supports teamwork and continuous improvement
Ability to work effectively and efficiently in a team environment
Ability to focus on important issues only
Able to employ a risk based approach
Regularly refocuses on results
Demonstrates a drive to exceed performance targets
Ability to handle multiple tasks and competing priorities concurrently and in a timely fashion
Prioritizes and monitors tasks progress
Makes realistic estimates of time and resource requirements
Preferred
Background in statistics, mathematics, engineering, chemistry, or biological sciences preferred
Six Sigma training preferred
Quality management or quality engineer training a plus
Company
CooperSurgical
CooperSurgical provides a full portfolio of medical and surgical products. It is a sub-organization of The Cooper Companies.
1001-5000 employees
H1B Sponsorship
CooperSurgical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (10)
2023 (10)
2022 (13)
2021 (5)
2020 (4)
Funding
Current Stage
Late StageLeadership Team
Lisa Fawcett
Executive Vice President, Strategy & Market Development
Recent News
MarketScreener
2025-08-29
2025-08-27
Company data provided by crunchbase