Sr. Quality Process Specialist
Job Description
Job Summary
Under minimal supervision, responsible for Quality process design, integration, implementation, and maintenance. Manage the Quality data integrity for Medline products including but not limited to, sterile products, medical devices, pharmaceuticals, biologics, cosmetics, medical foods, and dietary supplements. Support Quality Systems related activities, analyzes problems related to quality/regulatory information, and provides systems, and technical support in solving these problems. Support design, development, implementation, and testing of quality solutions and business acquisition integration as required to meet customer/regulatory requirements, and works with internal and external inputs to develop these solutionsJob Description
Responsibilities:
Administer and maintain quality systems.
Collect, analyze, and report quality data to track performance and compliance. Develop and implement improvements to processes and procedures.
Identifies and advises opportunities to improve quality systems and develop long-term strategies that support the success of the business.
Determine and create key quality metrics/indicators to track performance and compliance
Reviews and determine the application of various system compliance regulations. Ensure compliance to global regulatory requirements with internal procedures. Identify risk and compliance opportunities.
Implement and coordinate use of electronic documentation systems and training personnel.
Collaborate with cross-functional teams to deploy quality processes and systems. Consult and provide guidance to business partners.
Execute responsibilities as CRB team member. Lead CRB team in systems analysis and effectiveness measures.
Train and coach personnel to deliver optimal results based on the department’s goals.
Support hosting Notified body/ Registrar Quality Systems audits. Supports in customer and regulatory audits.
Provide project guidance, training, and coaching.
Preferred Qualifications:
Bachelor’s degree in a technical or scientific discipline.
At least 4 years of experience with medical device or pharma Quality
Knowledge of Food and Drug Administration (FDA), Quality System Regulations (QSR) and International Organization of Standardization (ISO).
Proficiency in Microsoft Suite, MS Visio, MS Project, Minitab.
Position requires travel up to 10% of the time for business purposes (within state and out of state).
Preferred Qualifications:
Experience with Medical Device and Pharma, multiple product types, and regulatory jurisdictions.
Experience with quality systems development and implementation.
Experience with Medical Device Design Controls, CE technical File Requirements, and 510K submissions.
Experience in the Medical Device and Pharmaceutical industry.
Experience hosting FDA/ISO GMP inspections.
Experience with SAP.
Experience with ETQ Reliance.
#LI-Hybrid
Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
The anticipated salary range for this position:
$85,280.00 - $123,760.00 AnnualThe actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.
Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click here. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.
We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here.
Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.
Job Summary
Under minimal supervision, responsible for Quality process design, integration, implementation, and maintenance. Manage the Quality data integrity for Medline products including but not limited to, sterile products, medical devices, pharmaceuticals, biologics, cosmetics, medical foods, and dietary supplements. Support Quality Systems related activities, analyzes problems related to quality/regulatory information, and provides systems, and technical support in solving these problems. Support design, development, implementation, and testing of quality solutions and business acquisition integration as required to meet customer/regulatory requirements, and works with internal and external inputs to develop these solutionsJob Description
Responsibilities:
Administer and maintain quality systems.
Collect, analyze, and report quality data to track performance and compliance. Develop and implement improvements to processes and procedures.
Identifies and advises opportunities to improve quality systems and develop long-term strategies that support the success of the business.
Determine and create key quality metrics/indicators to track performance and compliance
Reviews and determine the application of various system compliance regulations. Ensure compliance to global regulatory requirements with internal procedures. Identify risk and compliance opportunities.
Implement and coordinate use of electronic documentation systems and training personnel.
Collaborate with cross-functional teams to deploy quality processes and systems. Consult and provide guidance to business partners.
Execute responsibilities as CRB team member. Lead CRB team in systems analysis and effectiveness measures.
Train and coach personnel to deliver optimal results based on the department’s goals.
Support hosting Notified body/ Registrar Quality Systems audits. Supports in customer and regulatory audits.
Provide project guidance, training, and coaching.
Preferred Qualifications:
Bachelor’s degree in a technical or scientific discipline.
At least 4 years of experience with medical device or pharma Quality
Knowledge of Food and Drug Administration (FDA), Quality System Regulations (QSR) and International Organization of Standardization (ISO).
Proficiency in Microsoft Suite, MS Visio, MS Project, Minitab.
Position requires travel up to 10% of the time for business purposes (within state and out of state).
Preferred Qualifications:
Experience with Medical Device and Pharma, multiple product types, and regulatory jurisdictions.
Experience with quality systems development and implementation.
Experience with Medical Device Design Controls, CE technical File Requirements, and 510K submissions.
Experience in the Medical Device and Pharmaceutical industry.
Experience hosting FDA/ISO GMP inspections.
Experience with SAP.
Experience with ETQ Reliance.
#LI-Hybrid
Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
The anticipated salary range for this position:
$85,280.00 - $123,760.00 AnnualThe actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.
Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click here. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.
We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here.
Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.
About Medline Industries
Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care. Through its unique offering of world-class products, supply chain resilience and clinical practice expertise, Medline delivers improved clinical, financial and operational outcomes. Headquartered in Northfield, Illinois, the company employs 43,000 people worldwide and operates in over 100 countries and territories.
It has always been Medline's intention and purpose to create a great place to work for everyone. We believe tapping into the richness of our employees' diversity allows us to find innovative solutions for our customers, who themselves represent a diverse group both in the U.S. and around the world. The Belonging and Engagement team at Medline is dedicated to fostering an inclusive and supportive workplace culture. We focus on creating opportunities for employees to feel seen, supported, and connected through initiatives like Employee Resource Groups (ERGs), cultural awareness events, new hire engagement, and leadership training.
Every hour of every day, healthcare professionals rely on Medline to help them do their job. Our agile and resilient global team is determined to get our customers exactly what they need, at the right time, every time. If you're a self-starter, eager to grow your career within a high-performing environment, this is the place for you. Together, we make healthcare run better.
For more on all things Belonging at Medline Industries, check out our home page here.
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