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 ar met according to documented policies, procedures, standards and regulations.
Perform other duties as assigned.
The Experience, Skills, and Abilities Needed
Bachelor's Degree (Scientific or related technical field).
1-5 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
1-5 years of experience with medical device or other regulated industries preferred.
1-5 years of experience working in an ISO certified environment required.
Working knowledge of FDA QSR/ EUGMP regulations strongly preferred.
What STERIS Offers
We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being, and financial future.
Here is just a brief overview of what we offer
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
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Pay range for this opportunity is $80,000 -$100,000. This position is eligible for bonus participation.
Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc.
STERIS offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits: STERIS Benefits
Open until position is filled.
STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.
