Lead the organization’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 site senior management to provide strategic direction and development of the organization’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 organization’s Management Review process.
Ensure compliance with appropriate domestic regulatory and international standards and requirements.
Lead the organization'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 implement 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.
This individual has autonomy to perform the duties of Person Responsible for Regulatory Compliance (PRRC) on behalf of STERIS legal manufacturing entities under the EU MDR. This individual shall suffer no disadvantage within the organization in relation to proper fulfilment of his or her duties in lieu of article 15 of the EU MDR.
Perform other duties as assigned.
The Experience, Skills and Abilities Needed
Required
Bachelor’s degree in Engineering or related field.
Minium of 8 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
Minimum of 8 years of experience working in an ISO certified environment required.
Minimum of 2 years in a Quality leadership role.
Must fulfil the experience requirements listed in Article 15 of the EUMDR (PRRC).
Ability to travel 10 - 20% domestically, required.
Preferred
Minimum of 8years of experience with medical device or other regulated industries preferred.
ASQ, QSR Certification or familiarity with QSR/GMP regulations preferred.
Other
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.
Experience with statistical analysis software and Visio preferred.
What STERIS Offers
We value our employees and are committed to providing a comprehensive benefits package that supports your health, wellbeing, 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 $107,525.00 to 139,150.00. 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
STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity and the use of affirmative action programs 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.
