Lead and manage assigned Quality staff to ensure effective Customer complaint and CAPA management. * Lead and manage assigned Quality staff to effectively execute site calibration and maintenance ...
Lead and manage assigned Quality staff to ensure effective Customer complaint and CAPA management. * Lead and manage assigned Quality staff to effectively execute site calibration and maintenance ...
Experience with ServiceNow (Problem, Change management), Track wise (Change Management), Veeva (Document management, CAPA, Deviations, Change Management). Knowledge of cGMP regulations and guidelines ...
Experience with ServiceNow (Problem, Change management), Track wise (Change Management), Veeva (Document management, CAPA, Deviations, Change Management). Knowledge of cGMP regulations and guidelines ...
Senior Quality Manager
Columbus, OH · On-site
Oversee root cause analysis (RCA) and corrective/preventive action (CAPA) processes across the ... Manage supplier and vendor quality programs, including qualification, audits, and ongoing ...
Senior Quality Manager
Columbus, OH · On-site
Oversee root cause analysis (RCA) and corrective/preventive action (CAPA) processes across the ... Manage supplier and vendor quality programs, including qualification, audits, and ongoing ...
Quality Supervisor
Obetz, OH · On-site
Manage the CAPA process * Ensure all QA lab and production quality records are accurate, complete, and audit-ready Regulatory & Customer Compliance * Ensure all products meet regulatory, customer ...
Quality Supervisor
Obetz, OH · On-site
Manage the CAPA process * Ensure all QA lab and production quality records are accurate, complete, and audit-ready Regulatory & Customer Compliance * Ensure all products meet regulatory, customer ...
Oversee root cause analysis (RCA) and corrective/preventive action (CAPA) processes across the ... Manage supplier and vendor quality programs, including qualification, audits, and ongoing ...
Oversee root cause analysis (RCA) and corrective/preventive action (CAPA) processes across the ... Manage supplier and vendor quality programs, including qualification, audits, and ongoing ...
Supervisor, Quality
Mentor, OH · On-site
Lead and manage assigned Quality staff to ensure effective Customer complaint and CAPA management. * Lead and manage assigned Quality staff to effectively execute site calibration and maintenance ...
Supervisor, Quality
Mentor, OH · On-site
Lead and manage assigned Quality staff to ensure effective Customer complaint and CAPA management. * Lead and manage assigned Quality staff to effectively execute site calibration and maintenance ...
Oversee root cause analysis (RCA) and corrective/preventive action (CAPA) processes across the ... Manage supplier and vendor quality programs, including qualification, audits, and ongoing ...
Oversee root cause analysis (RCA) and corrective/preventive action (CAPA) processes across the ... Manage supplier and vendor quality programs, including qualification, audits, and ongoing ...
Quality Assurance Manager
Columbus, OH · On-site
Participates in follow-up meetings and CAPA. * Assists in writing/revising and maintaining task ... Previous project management experience is preferred. Skills and Abilities: * Ability to lead and ...
Quality Assurance Manager
Columbus, OH · On-site
Participates in follow-up meetings and CAPA. * Assists in writing/revising and maintaining task ... Previous project management experience is preferred. Skills and Abilities: * Ability to lead and ...
Quality Systems/ISO Rep
Chester, OH · On-site
Corrective and preventive actions (CAPA): Manage the process for identifying, documenting, and resolving non-conformities, and implement preventive measures to avoid recurrence. * Management of ...
Quality Systems/ISO Rep
Chester, OH · On-site
Corrective and preventive actions (CAPA): Manage the process for identifying, documenting, and resolving non-conformities, and implement preventive measures to avoid recurrence. * Management of ...
Participates in follow-up meetings and CAPA. * Assists in writing/revising and maintaining task ... Previous project management experience is preferred. Skills and Abilities: * Ability to lead and ...
Participates in follow-up meetings and CAPA. * Assists in writing/revising and maintaining task ... Previous project management experience is preferred. Skills and Abilities: * Ability to lead and ...
Environmental, Health, and Safety Manager
$74K - $101K/yr
Lead root cause investigations for injuries and near-misses; manage the CAPA process and drive reduction in recordable incidents using data-driven indicators. * Occupational Health: Manage site ...
Quick apply
Environmental, Health, and Safety Manager
$74K - $101K/yr
Lead root cause investigations for injuries and near-misses; manage the CAPA process and drive reduction in recordable incidents using data-driven indicators. * Occupational Health: Manage site ...
Environmental, Health, and Safety Manager
$74K - $101K/yr
Lead root cause investigations for injuries and near-misses; manage the CAPA process and drive reduction in recordable incidents using data-driven indicators. * Occupational Health: Manage site ...
Environmental, Health, and Safety Manager
$74K - $101K/yr
Lead root cause investigations for injuries and near-misses; manage the CAPA process and drive reduction in recordable incidents using data-driven indicators. * Occupational Health: Manage site ...
Senior Quality Manager
Mccomb, OH · On-site
Lead Root Cause Analysis (RCA) and Corrective Actions/Preventative Action (CAPA) investigations ... Manage multiple projects at a time * Direct various program activities within the plant * Influence ...
Senior Quality Manager
Mccomb, OH · On-site
Lead Root Cause Analysis (RCA) and Corrective Actions/Preventative Action (CAPA) investigations ... Manage multiple projects at a time * Direct various program activities within the plant * Influence ...
Manage and administer the CAPA process for both Invacare and Invamex, ensuring timely initiation, tracking, investigation, root cause analysis, implementation of actions, and verification of ...
Manage and administer the CAPA process for both Invacare and Invamex, ensuring timely initiation, tracking, investigation, root cause analysis, implementation of actions, and verification of ...
Environmental, Health, and Safety Manager
Miamisburg, OH · On-site
$74K - $101K/yr
Lead root cause investigations for injuries and near-misses; manage the CAPA process and drive reduction in recordable incidents using data-driven indicators. * Occupational Health: Manage site ...
Environmental, Health, and Safety Manager
Miamisburg, OH · On-site
$74K - $101K/yr
Lead root cause investigations for injuries and near-misses; manage the CAPA process and drive reduction in recordable incidents using data-driven indicators. * Occupational Health: Manage site ...
... CAPA) investigations Coach, teach, and mentor the QA and Food Safety teams to build bench strength ... Manage multiple projects at a time Direct various program activities within the plant Influence ...
... CAPA) investigations Coach, teach, and mentor the QA and Food Safety teams to build bench strength ... Manage multiple projects at a time Direct various program activities within the plant Influence ...
Experience with deviation investigations, CAPA management, and change control systems * Familiarity with pharmaceutical manufacturing processes and quality systems * Strong analytical, organizational ...
Experience with deviation investigations, CAPA management, and change control systems * Familiarity with pharmaceutical manufacturing processes and quality systems * Strong analytical, organizational ...
Senior Manager, Quality Data Analytics
Cincinnati, OH · On-site
$125K - $172K/yr
Oversee analytics supporting CAPA, complaints, audits, nonconformances, supplier quality, and ... Manage prioritization across multiple stakeholders and enterprise demands; and, * Other duties as ...
Senior Manager, Quality Data Analytics
Cincinnati, OH · On-site
$125K - $172K/yr
Oversee analytics supporting CAPA, complaints, audits, nonconformances, supplier quality, and ... Manage prioritization across multiple stakeholders and enterprise demands; and, * Other duties as ...
Lead complex root cause investigations and drive CAPA effectiveness * Monitor and manage quality-related budgets, including equipment and testing resources * Drive continuous improvement initiatives ...
Lead complex root cause investigations and drive CAPA effectiveness * Monitor and manage quality-related budgets, including equipment and testing resources * Drive continuous improvement initiatives ...
Lead complex root cause investigations and drive CAPA effectiveness * Monitor and manage quality-related budgets, including equipment and testing resources * Drive continuous improvement initiatives ...
Lead complex root cause investigations and drive CAPA effectiveness * Monitor and manage quality-related budgets, including equipment and testing resources * Drive continuous improvement initiatives ...
Capa Manager information
What does a CAPA Manager do?
A CAPA (Corrective and Preventive Action) Manager is responsible for overseeing an organization's CAPA process to ensure compliance with quality and regulatory requirements. They investigate quality issues, identify root causes, and implement corrective and preventive measures to prevent recurrence. CAPA Managers work closely with cross-functional teams to improve processes, maintain regulatory compliance, and enhance overall product or service quality.
What are some common challenges a CAPA Manager faces, and how are they typically addressed?
One common challenge CAPA Managers face is ensuring timely and thorough investigations into quality issues while coordinating input from multiple departments. Balancing the need for fast resolution with the rigor required for regulatory compliance can be demanding, especially in highly regulated industries like pharmaceuticals or medical devices. Successful CAPA Managers often address these challenges through clear process documentation, effective project management, and fostering strong collaboration among stakeholders. By leveraging root cause analysis tools and maintaining open communication, they help create a continuous improvement culture that benefits both the organization and its customers.
What are the key skills and qualifications needed to thrive in the Capa Manager position, and why are they important?
To thrive as a CAPA Manager (Corrective and Preventive Action Manager), you typically need a background in quality assurance, strong analytical and problem-solving abilities, and experience with regulatory compliance, often supported by a degree in a science or engineering field. Familiarity with quality management systems (QMS), risk management tools, root cause analysis methodologies (such as 5 Whys or Fishbone diagrams), and industry certifications like Six Sigma or ISO 9001 are highly valued. Outstanding candidates demonstrate excellent communication, leadership, and organizational skills to effectively drive cross-functional teams and ensure timely resolution of quality issues. These skills are crucial for identifying, addressing, and preventing compliance gaps or product issues, thereby maintaining high standards and avoiding costly regulatory penalties.

Full-time
Medical, Dental, Vision, Retirement, PTO
Posted 10 days ago
Job description
The Quality Supervisor leads a team of Quality specialists, technicians or inspectors focused on incoming product/component inspection, final QC inspection/testing of products, complaint investigation, NCR investigation, or production floor quality support. The Quality Supervisor develops and manages work assignments, analyzes and trends Quality performance data and utilizes problem solving methods to improve processes and eliminate Quality issues.In addition, as a contributor to Quality System compliance, the Quality Supervisor supports the site to ensure the Quality System adheres to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other regulatory standards, as applicable.
- Lead and manage assigned Quality staff to ensure effective Customer complaint and CAPA management.
- Lead and manage assigned Quality staff to effectively execute site calibration and maintenance records; training records; DHR records and environmental control monitoring.
- Lead and manage assigned Quality staff to effectively execute QC inspection procedures and capture associated non conformances.
- Lead and manage assigned Quality staff to effectively investigate non conformances.
- Lead the team in providing effective production floor Quality support.
- Lead and manage assigned Quality staff in effectively managing nonconforming materials including proper disposition and recordkeeping.
- Establish individual and team objectives to attain key metric performance and ensure alignment to overall Quality strategy.
- Analyze and trend Quality data to identify and drive product/service and process improvements.
- Lead the Team's talent development processes and knowledge development.
- Assume other duties as assigned.
Required:
- Bachelor's Degree (Engineering/Scientific)
- Minimum 4 years of production Quality and/or Quality Management Systems experience
- Minimum 4 years of experience in healthcare, medical device or other regulated industry
- Minimum 2 years of experience leading a team and/or supervising employees
Preferred:
- ASQ, QSR, or familiarity with QSR/GMP regulations preferred
Other:
- Customer Focused: Demonstrates a "Customer first" mindset. Responds with a sense of urgency
- Teamwork: Collaborates with others. Works in a professional manner to support team actions
- Results: Effectively manages work tasks. Is detail oriented and strives for continuous improvement. Ability to analyze technical issues. Ability to cope with change and shifting priorities
- Communication: Constructs clear written communication. Keeps manager and co-workers informed
- Job Knowledge: PC experience and working familiarity of common desktop applications including Excel and Word
- Initiative/Leadership: Takes ownership of task and projects and seeks clarification if unsure of direction
- Ability to analyze and interpret data; utilize problem solving methodologies and drive process improvements
We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being, and financial future.
Here is a brief overview of what we offer:
- Market competitive pay
- Extensive paid time off and (9) added holidays
- Excellent healthcare, dental, and vision benefits
- Long/short term disability coverage
- 401(K) with company match
- Maternity and parental leave
- Additional add on benefits/discounts for programs such as pet insurance
- Tuition reimbursement and continued educational programs
- Excellent opportunities for advancement in a stable long-term career
#LI-HT
Pay range for this opportunity is$79,687.50-$103,125.00.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
Open until position is filled.
STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity 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.
Employment Type: FULL_TIME