Supervisor, Quality Control
Elkton, MD, US
Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.
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, impactful solutions for patients.
Join us and help shape wherever we go next!
Advancing healthcare with heart
Job Summary
The Supervisor, Quality Control (QC) is responsible for the daily operations of the QC function in production areas of the Elkton plant. These operations include supervising, directing, motivating, and providing training and oversight to Quality Control staff to ensure appraisal of the quality of manufactured product. The Supervisor will ensure that sample collection and product appraisal are executed against specifications according to the control plans. They will also ensure that their team is properly scheduled, cross-trained, and deployed to execute in a timely fashion to support production schedules while maintaining product compliance. The group will work closely with Operations Quality Engineering, Manufacturing, and Engineering to sustain a state of compliance in which results are reported in a timely manner to the appropriate parties for follow-up after they are obtained. 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. As a Supervisor, this position will provide guidance, direction, and coaching to direct reports assigned to the group.
Job Details/Responsibilities
- 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
- Ensure that 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
- Identify the need to update SOPs and WIs and escalate and/or coordinate with appropriate technical functions to ensure procedures are compliant and accurate
- Understand and interact with the Manufacturing Execution system and ensure QC associates are trained on the system.
- Accountable 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
Job Responsibilities (continued)
- Effectively partner with Operations Managers and Supervisors to develop and implement strategies which promote the Terumo Quality Culture throughout operations.
- Ensure recording and reporting of required Quality and business metrics
- 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 support additional shifts outside of the position’s regular shift times as business needs dictate.
- Perform other job-related duties as assigned.
Working Conditions/Physical Requirements
Knowledge, Skills and Abilities (KSA)
- Strong organizational skills required to ensure maintenance of service level to executing QC testing and reporting.
- Outstanding communication skills, both verbal and written.
- Excellent analytical skills to understand & explain trends in test data
- Strong ability to lead a team of testing associates, while supporting professional development of direct reports
- Strong drive to achieve results and meet commitments.
- Demonstrated success at consistently achieving business and quality objectives.
Qualifications/ Background Experiences
- Associate’s degree required or equivalent combination of relevant work experience and education, BS from an accredited university preferred.
- Minimum 5 years' experience with increasing responsibility in manufacturing testing, QC, QA, technical lab testing or management, or other relevant manufacturing support role.
- Experience in a manufacturing or manufacturing support environment required.
- 2 years’ management of staff experience preferred
- Experience in a regulated industry preferred.
- Experience, training, or certifications in quality discipline is preferred.
It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.