Senior Manager, Quality

Isomedix Operations Inc. (US)•Libertyville, IL

6h•$115,000 - $140,000

About The Position

The Senior Manager, Quality Systems assumes overall responsibility in ensuring that their site(s)/operations maintain operational and quality systems in a state of compliance to domestic and international standards. The role is responsible for the organization, documentation, and maintenance of the quality system to be compliant with, as appropriate, the following standards: ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO 11137 and/or ISO 11135 and other applicable regulatory standards. The Senior Manager is responsible for execution of the quality management system within multiple facilities spread across geographical regions and/or countries or complex facilities with multiple modalities/technologies and operations streams (i.e. laboratories, radiation technology centers, dosimeter manufacturing, e-beam system manufacturing, calibration cells, etc.). This position is responsible for quality system execution and compliance within a complex network of technologies/modalities that operate within a heavily regulated environment and serve a diverse Customer-base with significant variance in product mix, including facilities that conduct Customer product testing and/or product evaluation, as well as manufacturing operations in certain regions. This leadership position is responsible for the development and implementation of the quality systems across multiple facilities/modalities within the AST division. In addition, the position will be responsible for all quality matters pertinent to the quality system in their facilities to maintain sustainable quality processes. The Senior Manager also supports the global Quality Operations organization by establishing strategic plans targeted at achieving global fiscal year objectives. The Senior Manager is also responsible for leading quality improvement initiatives for complex or multi-site processing and lab facilities. This position takes the lead in developing, adopting, and maintaining state-of-the-art quality practices for sites which have multi-faceted service lines and associated regulatory requirements. This position has the authority to cease processing if deemed necessary.

Requirements

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 of 6 years in a Quality leadership role inclusive of direct supervisory responsibilities
Excellent problem-solving skills
Focus on identification of potential issues and continuous improvement
Experience working on cross-functional teams and on own initiative
Effective interpersonal skills, ability to work independently under minimal guidelines and supervision
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 and ever-changing responsibilities
Mathematical skills including practical application of fractions, percentages, ratios, proportions, and algebra

Nice To Haves

Minimum 10 years of experience with medical device or other regulated industries
Experience managing employees in multiple facilities/countries/geographies
Sterilization experience
Strong working knowledge of FDA QSR/ EUGMP regulations

Responsibilities

Leading and directing the Quality Operations Leads and staff for their assigned facilities within country/multiple countries.
Ensuring product release is executed as per approved Work instructions and Customer specifications.
Leading the Quality Operations staff in their multiple facilities/modalities to ensure compliance to the overall Quality Management System and drive continuous improvement.
Ensuring the Operational Quality activities are consistent with the goals and objectives of the AST organization.
Identifying and leading countermeasure activities for sites where monthly key performance metric targets have not been achieved.
Coaching, managing, and monitoring staff through ongoing performance feedback and formal reviews, as well as demonstrating best practices in job function and development initiatives which target individual strengths and weaknesses.
Ensuring that the required initial and continuing training of Quality Operations personnel is implemented according to need.
Leading the implementation of quality system standards through providing direction to the Quality Operations Manager, Operational Quality Lead(s), Engineers/Analysts and Technicians in their facilities.
Monitoring facility non-conformances, Customer complaints, and audit findings from internal and external audits.
Performing periodic audits within the assigned facility and participating in other facilities as needed to support continuous monitoring of our quality system.
Owning the Customer and notified body quality/regulatory audit process at their facilities.
Providing regular feedback and communication on the status of active audits to the Operational Quality Zone Director.
Collaborating with operations management within their assigned facilities to develop sustainable remediation action plans.
Actively participating in assigned facility projects alongside the Operations Management team to identify opportunities for improvement and efficiency all while ensuring the spirit of the regulations that govern our business are never compromised.
Applying regulatory knowledge and judgment to the evaluation of quality concerns as well as regulatory compliance issues.
Leading support during Regulatory inspections process on-site at their facilities.
Assisting in gathering Inspector’s requests for information in a timely manner with the highest level of professionalism.
Implementing any remediation required as a result of an inspection immediately with a corrective action plan within their facility.
Directing implementation of Dosimetry or Biological Indicator systems / manufacturing (where applicable) within their facility/facilities ensuring compliance with all applicable regulations and standards.
Co-owning with Operations the continuous improvement efforts within the facility by participating in quality and performance improvement projects.
Providing feedback from quality staff to Senior Quality operations Management and Compliance Management on opportunities for improvement.
Monitoring Operational Quality facility expenses to ensure actual expenses are managed with the plan and the subsequent forecasts by quarter.
Promoting a safe, clean, and secure working environment by supporting procedures, rules, and regulations; supporting plant safety committees that evaluate plant machinery, equipment, and working conditions.
Conducting oneself in accordance with the principles of the STERIS Code of Business Conduct and complying with all Company policies.
Protecting company confidential information by properly storing, retrieving, and disseminating such information only to those authorized.
Exhibiting a commitment to the AST shared values of Customer Satisfaction and Continuous Improvement through ensuring defect-free workmanship, assisting others to meet the Customer’s needs, searching for efficient and effective ways to reduce waste, being active and accountable for Customer satisfaction, and satisfying the Customer’s needs with a sense of urgency.
Performing other duties as assigned.