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Job Title:  Senior Quality Manager

Req ID:  23317
Job Category:  Quality

Montgomery, AL, US, 36109

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.

The Senior Systems Quality Manager is responsible for leading quality improvement at Montgomery, AL manufacturing facility. As Sr. Quality Systems Manager, you will take the lead in developing, adopting, and maintaining above and beyond industry quality standards and practices. You will assume overall responsibility in ensuring that the site maintains operational and quality systems in a state of compliance with domestic and international standards.  You will also be responsible for the organization, documentation, and maintenance of the quality system to be compliant with, as appropriate, the following standards: IS0 9001, ISO 13485, MDSAP, and CFR Part 820/211, EU MDR, and other applicable standards. If operational excellence and quality is your passion, then we invite you to apply to join our team in Montgomery, AL! 

We are able to provide relocation assistance to candidates wanting to relocate to the Greater Montgomery Area! 

How will you be expected to Lead as a Sr. Quality Systems Manager?

  • Lead the organization’s Quality staff to ensure compliance to the overall Quality Management System and drive continuous improvement. 
  • 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 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 develop effective production and process controls.
  • Manage the complaint handling processes to ensure 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 the 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 the 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 the proper fulfilment of his or her duties in lieu of article 15 of the EU MDR.
  • Perform other duties as assigned.
     

What Skills, Abilities, and Experience will you need?

  • Bachelors Degree in Engineering or related field with the following additional experience required:
  • 10 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience required.
  • 10 years of experience with medical device or other regulated industries preferred.
  • 10 years of experience working in an ISO-certified environment required.
  • Minimum of 6 years in a Quality leadership role.
  • Must fulfill the experience requirements listed in Article 15 of the EUMDR (PRRC).
  • ASQ, QSR, or familiarity with QSR/GMP regulations preferred
  • 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 with desktop applications including Excel, Word, and PowerPoint.
  • Experience with statistical analysis software and Visio preferred
     

What STERIS can offer you!

This is a great opportunity to join a well-established, global company that will invest in your career growth over the long term. STERIS wouldn’t be where it is today without our incredible, talented people. That’s why we share in our success together by rewarding you for your hard work. Hiring people who are in it for the long run with STERIS is our ultimate goal.


We offer a comprehensive benefits package, including:

  • Relocation assistance if relocating from outside the greater Montgomery area
  • Competitive pay
  • Annual merit and bonus plans
  • Medical, vision, dental and life insurance
  • 401(k) with a company match
  • Paid vacation time and paid holidays
  • Tuition assistance
  • Opportunities for advancement
  • Please ask about location specific benefits in Montgomery, AL!

 

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STERIS is a $3B, publicly traded (NYSE: STE) organization with approximately 12,000 associates worldwide and operates in more than 100 countries.

If you need assistance completing the application process, please call 1 (440) 392.7047. This contact information is for accommodation inquiries only and cannot be used to check application status.

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.

The full affirmative action program, absent the data metrics required by § 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location’s HR Office during normal business hours.

Req ID:  23317
Job Category:  Quality

Montgomery, AL, US, 36109


Nearest Major Market: Montgomery

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