Engineering Jobs in Hainesville
24 positions found — Page 2
J
Structural Steel Project Estimator
🏢 Jobot
Salary not disclosed
Established, stable metals manufacturer looking for an experienced project Estimator to join the team! This Jobot Job is hosted by: Catherine Reid Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.
Salary: $85,000
- $105,000 per year A bit about us: Decades-old Metals Manufacturing company offering stability, training, and terrific career opportunity! Why join us? We work on great projects and have a terrific, talented team who has earned credibility in the space.
We work with integrity, experience, and compassion.
Our benefits package and long-term career growth are terrific
- come join us! Job Details Job Details: We are currently seeking an experienced, reliable metals manufacturing project Estimator to join our team.
This is a permanent, full-time position offering a competitive salary and benefits package.
As a Project Estimator, you will play a critical role in our company's projects, providing accurate and comprehensive cost estimates that drive our success.
You will be working alongside a team of dedicated professionals committed to delivering high-quality results.
This role requires a deep understanding of construction processes, excellent numerical skills, and an analytical mindset.
Responsibilities: 1.
Review and comprehend technical and administrative documents such as Requests for Proposals (RFPs) and blueprints.
2.
Develop comprehensive, detailed cost estimates that incorporate material, labor, equipment, and production timelines.
3.
Coordinate with project managers, engineers, and other construction professionals to gather necessary data for estimates.
4.
Use specialized software and other tools to create and present estimates.
5.
Evaluate suppliers and subcontractors to ensure quality and cost-effectiveness.
6.
Participate in the negotiation and awarding of contracts.
7.
Monitor project progress to identify variances between estimated and actual costs and implement corrective actions when necessary.
8.
Maintain current knowledge of market trends, pricing, and construction processes.
9.
Assist in the preparation of budget and project reports.
Qualifications: 1.
Bachelor's Degree in Structural Engineering, Civil Engineering, or a related field.
2.
A minimum of 5 years’ experience in metals project estimating, with a proven track record of creating accurate and detailed estimates.
3.
Proficiency in reading and interpreting blueprints and technical documents.
4.
Strong knowledge of construction materials, processes, and equipment.
5.
Proficiency in using estimating software and other relevant computer applications.
6.
Excellent numerical skills and an analytical mindset.
7.
Strong negotiation and communication skills.
8.
Ability to work under pressure and meet strict deadlines.
9.
Detail-oriented with strong organizational and project management skills.
10.
A team player with the ability to work independently when needed.
Join us and be a part of a team that values professionalism, integrity, and commitment to excellence.
We look forward to receiving your application! Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.
Jobot is an Equal Opportunity Employer.
We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws.
Jobot also prohibits harassment of applicants or employees based on any of these protected categories.
It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions.
Sometimes Jobot is required to perform background checks with your authorization.
Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.
Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at /legal.
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Jobot, and/or its agents and contracted partners.
Frequency varies for text messages.
Message and data rates may apply.
Carriers are not liable for delayed or undelivered messages.
You can reply STOP to cancel and HELP for help.
You can access our privacy policy here: /privacy-policy
Salary: $85,000
- $105,000 per year A bit about us: Decades-old Metals Manufacturing company offering stability, training, and terrific career opportunity! Why join us? We work on great projects and have a terrific, talented team who has earned credibility in the space.
We work with integrity, experience, and compassion.
Our benefits package and long-term career growth are terrific
- come join us! Job Details Job Details: We are currently seeking an experienced, reliable metals manufacturing project Estimator to join our team.
This is a permanent, full-time position offering a competitive salary and benefits package.
As a Project Estimator, you will play a critical role in our company's projects, providing accurate and comprehensive cost estimates that drive our success.
You will be working alongside a team of dedicated professionals committed to delivering high-quality results.
This role requires a deep understanding of construction processes, excellent numerical skills, and an analytical mindset.
Responsibilities: 1.
Review and comprehend technical and administrative documents such as Requests for Proposals (RFPs) and blueprints.
2.
Develop comprehensive, detailed cost estimates that incorporate material, labor, equipment, and production timelines.
3.
Coordinate with project managers, engineers, and other construction professionals to gather necessary data for estimates.
4.
Use specialized software and other tools to create and present estimates.
5.
Evaluate suppliers and subcontractors to ensure quality and cost-effectiveness.
6.
Participate in the negotiation and awarding of contracts.
7.
Monitor project progress to identify variances between estimated and actual costs and implement corrective actions when necessary.
8.
Maintain current knowledge of market trends, pricing, and construction processes.
9.
Assist in the preparation of budget and project reports.
Qualifications: 1.
Bachelor's Degree in Structural Engineering, Civil Engineering, or a related field.
2.
A minimum of 5 years’ experience in metals project estimating, with a proven track record of creating accurate and detailed estimates.
3.
Proficiency in reading and interpreting blueprints and technical documents.
4.
Strong knowledge of construction materials, processes, and equipment.
5.
Proficiency in using estimating software and other relevant computer applications.
6.
Excellent numerical skills and an analytical mindset.
7.
Strong negotiation and communication skills.
8.
Ability to work under pressure and meet strict deadlines.
9.
Detail-oriented with strong organizational and project management skills.
10.
A team player with the ability to work independently when needed.
Join us and be a part of a team that values professionalism, integrity, and commitment to excellence.
We look forward to receiving your application! Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.
Jobot is an Equal Opportunity Employer.
We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws.
Jobot also prohibits harassment of applicants or employees based on any of these protected categories.
It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions.
Sometimes Jobot is required to perform background checks with your authorization.
Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.
Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at /legal.
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Jobot, and/or its agents and contracted partners.
Frequency varies for text messages.
Message and data rates may apply.
Carriers are not liable for delayed or undelivered messages.
You can reply STOP to cancel and HELP for help.
You can access our privacy policy here: /privacy-policy
Not Specified
M
Supply Chain Analyst - SPT
Salary not disclosed
Job Summary Job Description Summary Under general supervision, identify, conduct, and analyze supply chain data and projects.
Define issues, identify resource needs, and develop project plans.
Facilitate projects from concept to completion.
Job Description Responsibilities: Plan and prepare supply chain and operational analysis.
Monitor accuracy, timeliness and integrity of data for analysis and reporting.
Conduct root cause analysis, problem solving, and process improvement or analytics projects.
Establish, develop, and manage Supply Chain projects.
Identify resource needs and monitor project progress.
Recommend, develop, create and implement standard reporting for routine business reports and ad hoc reporting.
Identify data and reporting tools necessary to perform supply chain and operational analysis.
Communicate the results of key projects and recommend actions/provide guidance on supply chain and operational problems.
Communicate cross functionally with internal and external business partners to identify opportunities for process improvement and root cause analyses including creating metrics dashboards/reporting, sharing information with peers and direct manager, using data to identify issues/solutions, and recommending actions or improvements.
Requirements: Education Bachelor’s degree in Supply Chain Management, Industrial Engineering, Finance, Accounting, Information Services, Mathematics or Applied Statistics.
Relevant Work Experience Experience in project management and data analysis.
At least 2 years of operations and/or supply chain experience.
Experience communicating with internal and external business partners and cross functional teams with various audiences.
Additional Intermediate level skills in Microsoft Access, SQL, Tableau, and/or PowerBI (for example: designing and creating simple queries, modifying data types, adding dates, working with required fields and/or creating labels).
Intermediate level skill in Microsoft Excel (for example: using SUM function, V Look Up, setting borders, pivot tables, setting column width, inserting charts, using text wrap, sorting, setting headers and footers and/or print scaling).
Experience calculating figures and amounts such as discounts, interest, commissions, proportions, percentages and volume.
Experience applying standard financial, accounting and business problem-solving skills to business problems.
Preferred Qualifications: Relevant Work Experience Experience with SAP strongly preferred.
Certification / Licensure CPIM, CSCP, or APICS certification.
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: $67,000.00
- $101,000.00 Annual The 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.
Define issues, identify resource needs, and develop project plans.
Facilitate projects from concept to completion.
Job Description Responsibilities: Plan and prepare supply chain and operational analysis.
Monitor accuracy, timeliness and integrity of data for analysis and reporting.
Conduct root cause analysis, problem solving, and process improvement or analytics projects.
Establish, develop, and manage Supply Chain projects.
Identify resource needs and monitor project progress.
Recommend, develop, create and implement standard reporting for routine business reports and ad hoc reporting.
Identify data and reporting tools necessary to perform supply chain and operational analysis.
Communicate the results of key projects and recommend actions/provide guidance on supply chain and operational problems.
Communicate cross functionally with internal and external business partners to identify opportunities for process improvement and root cause analyses including creating metrics dashboards/reporting, sharing information with peers and direct manager, using data to identify issues/solutions, and recommending actions or improvements.
Requirements: Education Bachelor’s degree in Supply Chain Management, Industrial Engineering, Finance, Accounting, Information Services, Mathematics or Applied Statistics.
Relevant Work Experience Experience in project management and data analysis.
At least 2 years of operations and/or supply chain experience.
Experience communicating with internal and external business partners and cross functional teams with various audiences.
Additional Intermediate level skills in Microsoft Access, SQL, Tableau, and/or PowerBI (for example: designing and creating simple queries, modifying data types, adding dates, working with required fields and/or creating labels).
Intermediate level skill in Microsoft Excel (for example: using SUM function, V Look Up, setting borders, pivot tables, setting column width, inserting charts, using text wrap, sorting, setting headers and footers and/or print scaling).
Experience calculating figures and amounts such as discounts, interest, commissions, proportions, percentages and volume.
Experience applying standard financial, accounting and business problem-solving skills to business problems.
Preferred Qualifications: Relevant Work Experience Experience with SAP strongly preferred.
Certification / Licensure CPIM, CSCP, or APICS certification.
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: $67,000.00
- $101,000.00 Annual The 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.
Not Specified
M
Senior Engineer
🏢 Medline Industries - Transportation & Operations
Salary not disclosed
Job Summary Join Medline’s high‑performance team at our SPT facility in Mundelein, IL.
This site is a critical part of the company’s sterile product manufacturing footprint, supporting production, quality, warehousing, and maintenance functions.
The work performed here helps ensure healthcare providers have access to dependable, ready‑to‑use procedure trays that support efficient and safe patient care.
As a key contributor, you will plan, organize, and control increased productivity projects from conceptual stages through production cycles in order to optimize profit and meet marketing, financial, and corporate growth objectives.
Investigate current operations practices and scope, develop and implement changes that will improve operational productivity, and provide subject matter expertise.
Job Description Responsibilities: Analyze, review, and recommend technological solutions and innovative techniques to reduce Medline’s expenses and improve cost structure while maintaining or improving quality.
Analyze, review, recommend, and implement technological solutions and innovative techniques to reduce Medline’s expenses and improve cost structure while maintaining or improving quality.
Lead various scale projects from concept to realization involving individuals from multiple departments and disciplines.
Develop up to large-scale project plans to include action steps, schedules, etc.
to enhance ability to deliver quality projects on-time and within budget.
Perform complex assignments to develop new and/or enhance existing procedures, statistical analysis, inspections, and validation activities.
Conduct training, when appropriate, on quality assurance and/or engineering concepts and tools, including but not limited to inspection, measurement, test methods, process validation, DOE, and comprehensive equipment operation procedures.
Subject matter expert associated with content, processes, and procedures.
Apply functional knowledge to the design and customization of workflow systems that provide seamless integration.
Be aware of industry standards and understanding of cost benefit analysis to justify tasks/projects.
Provide specialized expertise to the company through project, account and people management.
Requirements: Education Bachelor’s degree in an Engineering discipline.
Additional: At least 4 years engineering experience.
Technical writing, research paper writing, and/or experimental design experience.
ERP systems knowledge and experience.
Intermediate skill level in computer and systems use (Microsoft Word, PowerPoint, and Excel).
International travel required (10-20%) 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: $92,000.00
- $138,000.00 Annual The 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.
This site is a critical part of the company’s sterile product manufacturing footprint, supporting production, quality, warehousing, and maintenance functions.
The work performed here helps ensure healthcare providers have access to dependable, ready‑to‑use procedure trays that support efficient and safe patient care.
As a key contributor, you will plan, organize, and control increased productivity projects from conceptual stages through production cycles in order to optimize profit and meet marketing, financial, and corporate growth objectives.
Investigate current operations practices and scope, develop and implement changes that will improve operational productivity, and provide subject matter expertise.
Job Description Responsibilities: Analyze, review, and recommend technological solutions and innovative techniques to reduce Medline’s expenses and improve cost structure while maintaining or improving quality.
Analyze, review, recommend, and implement technological solutions and innovative techniques to reduce Medline’s expenses and improve cost structure while maintaining or improving quality.
Lead various scale projects from concept to realization involving individuals from multiple departments and disciplines.
Develop up to large-scale project plans to include action steps, schedules, etc.
to enhance ability to deliver quality projects on-time and within budget.
Perform complex assignments to develop new and/or enhance existing procedures, statistical analysis, inspections, and validation activities.
Conduct training, when appropriate, on quality assurance and/or engineering concepts and tools, including but not limited to inspection, measurement, test methods, process validation, DOE, and comprehensive equipment operation procedures.
Subject matter expert associated with content, processes, and procedures.
Apply functional knowledge to the design and customization of workflow systems that provide seamless integration.
Be aware of industry standards and understanding of cost benefit analysis to justify tasks/projects.
Provide specialized expertise to the company through project, account and people management.
Requirements: Education Bachelor’s degree in an Engineering discipline.
Additional: At least 4 years engineering experience.
Technical writing, research paper writing, and/or experimental design experience.
ERP systems knowledge and experience.
Intermediate skill level in computer and systems use (Microsoft Word, PowerPoint, and Excel).
International travel required (10-20%) 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: $92,000.00
- $138,000.00 Annual The 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.
Not Specified
M
Sr. Manager Regulatory Compliance, Recall
🏢 Medline Industries - Transportation & Operations
Salary not disclosed
Job Summary This role is responsible for leading the corporate recall team.
Management of the recall team will include ensuring timely, compliant, and effective execution of recalls, corrections, and removals, while managing cross-functional teams and interfacing with regulatory authorities such as the FDA.
Job Description Responsibilities: Lead the corporate recall team and clinical product surveillance teams.
Develop and coach employees across all teams.
Lead the planning and execution of voluntary and mandatory recalls, product corrections, and removals in accordance with FDA regulations.
Participate in and manage team members who participate in Health Hazard Evaluation (HHE) meetings and assist in recall and field action decisions, including determination of recall strategy.
Ensure timely submission of FDA Form 806 and related documentation, as well as timely submissions of status reports and termination requests.
Maintain compliance with 21 CFR Part 7 (Recall Policy) and 21 CFR Part 806 (Reports of Corrections and Removals).
Maintain compliance with 21 CFR Part 803 (Medical Device Reporting) and ensure Medline’s MDR reporting strategy aligns with FDA requirements.
Serve as the primary liaison with FDA as it relates to recall and adverse event communication.
Monitor and interpret regulatory changes related to field actions, adverse event requirements, and risk management, and ensure internal procedures are updated accordingly.
Ensure timelines for all projects and deadlines are being met by the team.
Provide routine updates to Management on team performance and progress on projects.
Facilitate internal meetings with cross-functional teams and ensure alignment across stakeholders, including Sales Leadership and Divisional Leadership.
Management Responsibilities: Typically manages through multiple Managers and/or Supervisors Oversee major projects/programs/outcomes Budget responsibility Interpret and execute policies for departments/projects; develop, recommend and implement new policies or modifications to existing policies Provide general guidelines and parameters for staff functioning Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies Qualifications: Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, or related field Minimum 7 years of experience in medical device regulatory compliance or quality assurance, with at least 3 years in recall management or clinical product surveillance.
Deep understanding of FDA regulations including 21 CFR Part 7, Part 806, Part 803, and ISO 13485.
Proven experience managing complex recall events and regulatory submissions.
Strong leadership, communication, and project management skills.
Experience with FDA audits and internal quality audits.
Preferred Qualifications: At least 5 years of direct experience with recall management 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: $154,000.00
- $231,000.00 Annual The 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.
Management of the recall team will include ensuring timely, compliant, and effective execution of recalls, corrections, and removals, while managing cross-functional teams and interfacing with regulatory authorities such as the FDA.
Job Description Responsibilities: Lead the corporate recall team and clinical product surveillance teams.
Develop and coach employees across all teams.
Lead the planning and execution of voluntary and mandatory recalls, product corrections, and removals in accordance with FDA regulations.
Participate in and manage team members who participate in Health Hazard Evaluation (HHE) meetings and assist in recall and field action decisions, including determination of recall strategy.
Ensure timely submission of FDA Form 806 and related documentation, as well as timely submissions of status reports and termination requests.
Maintain compliance with 21 CFR Part 7 (Recall Policy) and 21 CFR Part 806 (Reports of Corrections and Removals).
Maintain compliance with 21 CFR Part 803 (Medical Device Reporting) and ensure Medline’s MDR reporting strategy aligns with FDA requirements.
Serve as the primary liaison with FDA as it relates to recall and adverse event communication.
Monitor and interpret regulatory changes related to field actions, adverse event requirements, and risk management, and ensure internal procedures are updated accordingly.
Ensure timelines for all projects and deadlines are being met by the team.
Provide routine updates to Management on team performance and progress on projects.
Facilitate internal meetings with cross-functional teams and ensure alignment across stakeholders, including Sales Leadership and Divisional Leadership.
Management Responsibilities: Typically manages through multiple Managers and/or Supervisors Oversee major projects/programs/outcomes Budget responsibility Interpret and execute policies for departments/projects; develop, recommend and implement new policies or modifications to existing policies Provide general guidelines and parameters for staff functioning Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies Qualifications: Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, or related field Minimum 7 years of experience in medical device regulatory compliance or quality assurance, with at least 3 years in recall management or clinical product surveillance.
Deep understanding of FDA regulations including 21 CFR Part 7, Part 806, Part 803, and ISO 13485.
Proven experience managing complex recall events and regulatory submissions.
Strong leadership, communication, and project management skills.
Experience with FDA audits and internal quality audits.
Preferred Qualifications: At least 5 years of direct experience with recall management 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: $154,000.00
- $231,000.00 Annual The 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.
Not Specified