Senior Manager, Quality Systems - Mentor
1 day ago
Job description
At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.
Position Summary
The Senior Quality Manager assumes overall responsibility in ensuring that the site maintains operational and quality systems in a state of compliance to domestic and international standards.
IS0 9001, ISO 13485, MDSAP and FDA 21 CFR Part 820.
This role leads the local site(s) efforts focused on product/service quality improvement, supplier quality, new product/service development quality and quality system compliance.
The Senior Quality Manager serves as the Management Representative for the site(s) and is responsible for ensuring the quality system meets all applicable regulatory standards.
This position also takes the lead in developing, adopting and maintaining state-of-the-art quality practices for multi-site and complex product and service lines.
What You'll do as a Sr Manager, Quality SystemsLead the business unit's Quality staff to ensure compliance to the overall Quality Management System and drive Continuous Improvement.
Lead the business unit's Quality staff to ensure alignment to manufacturing and servicing operations, support Lean efforts and drive quality improvement for products and services.
Work closely with Senior Management to provide strategic direction and development of the business unit's quality strategies and tactics.Provide quality viewpoints and opinions on future product and service development.
Provide coaching, mentoring and leadership to the Quality staff.
Serve as the site's Management Representative and lead the business unit's Management Review process.
Ensure compliance with appropriate domestic regulatory and international standards and requirements.
Lead the business unit's continuous improvement process; including data analysis, improvement projects and process capability to improve key metrics as measured by the product/service quality dashboard.
Lead and develop effective production and process controls.Manage the complaint handling processes to insure customer responsiveness and product and process improvements.
Ensure compliance to the New Product Development process and assurance that the Product Requirements Document includes key quality performance metrics.
Assess new designs for manufacturability, testability and reliability to ensure the Quality risks and deliverables of the New Product Development process meet the required application reliability and design intent.
Determine supplier qualification risks based upon criticality of component and supplier process capability.The position requires a level of authority to conduct and direct required activities such as quality planning, personnel management and regulatory compliance.
Perform other duties as assignedThe Experience, Skills, And Abilities Needed
Required:
Bachelor's Degree (Engineering or related technical field)
Minimum 10 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience
Minimum 10 years of experience working in an ISO certified environment
Minimum 6 years in a Quality leadership role
Focus on identification of potential issues and continuous improvement
Experience working on cross-functional teams and on own initiative
Preferred:
Experience with statistical analysis software and Visio
Minimum 10 years of experience with medical device or other regulated industries
ASQ, QSR or familiarity with QSR/GMP regulations
Other:
Excellent problem-solving skills
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
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.
Market competitive pay
Extensive paid time off and (9) added holidays
Excellent healthcare, dental, and vision benefits
Long/short term disability coverage
401(K) with company match
Maternity and parental leave
Additional add on benefits/discounts for programs such as pet insurance
Tuition reimbursement and continued educational programs
Excellent opportunities for advancement in a stable long-term career
Pay range for this opportunity is $122, $158, 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.
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