The Manager, Quality Control is responsible for managing quality operations functions within the respective manufacturing facility. S/he is responsible for ensuring compliance with the applicable regulations of all countries in which Terumo Medical either manufactures or distributes products including, but not limited to the U.S. Quality System Regulation, Japanese Pharmaceutical Affairs Laws, the Canadian Quality System Regulation, and the Medical Device Directive.
Establish and promote a work environment that supports compliance with the TMC Quality System and Terumo's policies
Oversee the daily operations of the QC function and QC associates and processes related to incoming inspection and release of finished goods
Establish systems, management structure, and procedures to ensure sample collection and product appraisal are executed against specifications according to the control plans
Maintain a state of compliance in which results are reported in a timely manner to the appropriate parties for follow-up after they are obtained
Ensure appropriate scheduling, staffing, and support of QC associates to provide adequate coverage to the manufacturing area
Guarantee the QC team receives the requisite training on the necessary systems and equipment to execute their jobs
Write/maintain/update SOPs and Work Instructions governing activities of the QC team or identify the need to update SOPs and WIs and coordinate with appropriate technical functions
Understand and interact with the Manufacturing Execution system and ensure QC associates are trained on the system
Responsible for hiring and disciplinary actions related to QC associates
Work closely with Operations Quality Engineering, DHR Review, MES Quality, Manufacturing, and Engineering teams to identify, prioritize, communicate, and resolve Quality issues quickly
Track appraisal costs, resource allocation, and other metrics to optimize efficiency of the QC team and maintain Quality Performance Indicators in support of management oversight activities
Identify non-conformance trends and work with Quality Engineering and other technical functions to develop investigation plans as necessary
Effectively partner with Operations Managers and Supervisors to develop and implement strategies which promote the Terumo Quality Culture throughout operations
Support the preparation and conduct of compliance forums such as Quality System Management Reviews, Change Board Meetings, NC/CAPA Board meetings etc.
Establish and promote a work environment that supports compliance with the TMC Quality System and Terumo's policies
Oversee the daily operations of the QC function and QC associates and processes related to incoming inspection and release of finished goods
Establish systems, management structure, and procedures to ensure sample collection and product appraisal are executed against specifications according to the control plans
Maintain a state of compliance in which results are reported in a timely manner to the appropriate parties for follow-up after they are obtained
Ensure appropriate scheduling, staffing, and support of QC associates to provide adequate coverage to the manufacturing area
Guarantee the QC team receives the requisite training on the necessary systems and equipment to execute their jobs
Write/maintain/update SOPs and Work Instructions governing activities of the QC team or identify the need to update SOPs and WIs and coordinate with appropriate technical functions
Understand and interact with the Manufacturing Execution system and ensure QC associates are trained on the system
Responsible for hiring and disciplinary actions related to QC associates
Work closely with Operations Quality Engineering, DHR Review, MES Quality, Manufacturing, and Engineering teams to identify, prioritize, communicate, and resolve Quality issues quickly
Track appraisal costs, resource allocation, and other metrics to optimize efficiency of the QC team and maintain Quality Performance Indicators in support of management oversight activities
Identify non-conformance trends and work with Quality Engineering and other technical functions to develop investigation plans as necessary
Effectively partner with Operations Managers and Supervisors to develop and implement strategies which promote the Terumo Quality Culture throughout operations
Support the preparation and conduct of compliance forums such as Quality System Management Reviews, Change Board Meetings, NC/CAPA Board meetings etc.
Additional responsibilities may include, but are not limited to, enforcing compliance to Terumo's quality policy; front line identification and triage of Quality issues on the manufacturing floor; participation in audits; engagement in projects to develop new test methods, equipment, and/or procedures; facilitating execution of non-standard testing relating to reselection, rework, or engineering protocols; and participating in root cause investigations as necessary
May be required to occasionally support additional shifts outside of the position's regular shift times as business needs dictate
Perform other job-related duties as assigned
Knowledge Skills & Abilities
Strong organizational skills required to develop, organize, maintain, and ensure operation of a group of QC associates who must maintain adequate service level in executing QC testing and reporting.
Prior experience in medical device manufacturing environment coupled with certifications from ASQ preferred
Ability to analyze and interpret all regulatory and quality guidelines as needed
Experience in QC testing, equipment, and/or measurement science preferred
Demonstrate a strong "business partner" approach and attitude providing creative and innovative solutions that meet quality standards
Qualifications
Bachelor's degree in engineering/science/math required or equivalent combination of relevant work experience and education
Minimum of 10 years Quality Assurance/Control experience
Minimum 2 years management experience
Experience leading a testing lab or QC function preferred
Must be proficient in Microsoft Excel, Word, PowerPoint, and Outlook
We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come.?
At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, sustainable solutions for patients.