Quality Analyst jobs in United States
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STERIS · 5 hours ago

Quality Analyst

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. The Quality Analyst is responsible for assisting in the administration of the quality management system, ensuring adherence to various regulatory standards, and leading quality improvement initiatives. This role involves coordinating investigations, managing quality system policies, and collaborating with other departments to maintain quality and regulatory compliance.

BiotechnologyHealth CareMedical Device
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H1B Sponsor Likelynote
Hiring Manager
Mina Ozturk
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Responsibilities

Coordinate day-to-day tasks and direction for Quality Technicians/Senior Quality Technicians by providing technical support, mentoring and oversight
Responsible for oversight of all product and/or report pre-reviews and releases conducted by Quality Technicians/Senior Quality Technicians
Responsible for executing product and/or report releases for all processing runs/lab samples containing a non-conformance, including management of Customer communication and leading the associated non-conformance investigations
Initiate and/or participate in corrective actions, problem-solving and continuous improvement activities
Perform internal audits at other AST facilities, including identification of non-compliances and report generation. Responsible for managing remediation of internal audit observations assigned by site Quality Manager
Manage creation of new quality system policies and procedures and revisions to existing policies/procedures
Review collected data to perform statistical analysis and recommend process changes to improve quality
Monitor and report on performance metrics
Instruct other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques
Collaborate with other departments and facilities within the company on quality related issues
Lead quality system programs (i.e. calibration, maintenance, training, CAPA, complaints, non-conformances, supplier quality, management review, operational qualifications, document control, change control, risk management, etc.)
Overall responsibilities include commitment to ensure external and internal requirements are met according to documented policies, procedures, standards and regulations
Perform other duties as assigned

Qualification

ISO 9001ISO 13485FDA regulationsStatistical analysisQuality management systemPC experienceMathematical skillsProblem-solvingOrganizational skillsCommunication skills

Required

Bachelor's degree (Scientific or related technical field)
Minimum of 1 year of combined Manufacturing/Quality Engineering and/or Quality Systems experience
Minimum of 1 year of experience working in an ISO certified environment required
Excellent problem-solving skills
Focus on identification of potential issues and continuous improvement
Experience working on cross-functional teams and on own initiative
Demonstrated excellent organizational, oral and written communications skills
Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint
Ability to work in a fast-paced, regulated environment with strict deadlines
Mathematical skills including practical application of fractions, percentages, ratios, proportions and algebra

Preferred

Minimum of 1 year experience with medical device or other regulated industries, preferred
Working knowledge of FDA QSR/ EUGMP regulations strongly preferred

Benefits

Market Competitive pay
Extensive Paid Time Off and added Holidays
Excellent Healthcare, Dental and Vision benefits
Long- and Short-Term Disability coverage
401(k) with a company match
Maternity and Paternity Leave
Additional add-on benefits / discounts for programs such as Pet Insurance
Tuition Reimbursement and continuing education programs
Excellent opportunities for advancement in a stable long-term career

Company

STERIS is a leading provider of infection prevention and other procedural products and services, focused primarily on healthcare, pharmaceutical and medical device Customers.

H1B Sponsorship

STERIS 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 (26)
2024 (28)
2023 (15)
2022 (33)
2021 (18)
2020 (19)

Funding

Current Stage
Public Company
Total Funding
$0.28M
2010-05-21Post Ipo Debt· $0.28M
1998-12-01IPO

Leadership Team

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Daniel Carestio
President and CEO, STERIS
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Walter Rosebrough
CEO Emeritus & Senior Advisor
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Company data provided by crunchbase