Mgr QA - Risk Management Process

Medline Industries, LP; Northfield Township (IL); In loco; USD 116.000 - 174.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

401(k) contributions

Paid time off

Descrizione del lavoro

Medline Industries, LP in the United States seeks a Quality & Regulatory Leader to manage quality and compliance for assigned product lines. You will adapt plans to resource and operational challenges and liaise with divisions, suppliers, and manufacturing to ensure quality products and customer satisfaction.

You will drive investigations, continuous improvement projects, and design/validation planning to ensure compliance with QSR, GMP, and ISO standards across regions.

Competenze

• Bachelor's degree in engineering, science, or technical field, or relevant experience.
• 4+ years in design/operation of medical device or drug combination product platforms with quality/regulatory exposure.
• Knowledge of 21CFR 820, ISO 13485, ISO 14971, MDSAP, MDR and related standards.

Mansioni

• Ensure quality and regulatory compliance (QSR, GMP, ISO) across product lifecycle and regions.
• Liaise with divisions, suppliers, manufacturing, and operations to ensure quality and customer satisfaction.
• Lead investigations of complaints and drive corrective actions and improvements.
• Identify and manage execution of continuous improvement projects.
• Assist in product evaluation from QA/regulatory perspectives and plan design/testing/validation activities.
• Resolve quality issues to achieve customer satisfaction and timely resolution.
• Oversee staff and budgets as applicable, and enforce organizational policies.

Conoscenze

Regulatory compliance knowledge

Data analysis

Project management

Advanced Excel

Travel up to 25%

Formazione

Bachelor's degree in Engineering/Science

Descrizione del lavoro

Job Summary

Responsible for managing the quality and compliance for applicable products and processes for assigned department(s). Adapt departmental plans and priorities to address resource and operational challenges.

Job Description

MAJOR RESPONSIBILITIES:

• Ensure quality and regulatory compliance with applicable regulations (ex. QSR, GMP,ISO) pertaining to the applicable life cycle and regions of distribution for the product.

• Acts as a liaison with the Divisions, Suppliers, Manufacturing, and/or Operations to ensure quality products and customer satisfaction.

• Manage complaints and develop new approaches to solve problems identified during the investigation process.

• Identify and manage the execution of continuous improvement projects.

• Assist the division in product evaluation from a quality assurance and regulatory compliance standpoint. Assist in the planning of the design, testing, inspection, and process validations to assure quality products or components.

• Ensure all quality issues are resolved to customer satisfaction, in a timely manner.

• Resolve issues relating to product or production quality by interfacing with internal and external customers.
  Management responsibilities include:

• Typically oversees professional employees/teams OR typically manages non-professional employees through Supervisors in manufacturing, distribution or office environments

• Day-to-day operations of a group of employees;

• May have limited budgetary responsibility and usually contributes to budgetary impact;

• Interpret and execute policies for departments/projects and develops.

• 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.

MINIMUM JOB REQUIREMENTS:

Education:

• Typically requires a Bachelor’s degree in Engineering, Science, or Technical Field, or relevant experience.

Certification / Licensure:

• None

Work Experience:

• At least 4 years of experience related to the design/operation of medical device or drug combination product platforms, design controls, risk management, including working in compliance with QSR/GMP/ISO requirements or other regulated industries (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR).

Knowledge / Skills / Abilities:

• Broad technical knowledge of relevant standards and regulations (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR etc.)
• Proficiency in analyzing and reporting data in order to identify issues, trends, or exceptions to drive improvement of results and find solutions.
• Demonstrated ability to control and coordinate concurrent projects, competing priorities and critical deadlines.
• Advanced level skill in Microsoft Excel (for example: using AVERAGE function, merging and centering cells, printing centered page and/or creating a pivot table).
• Position requires travel up to 25% of the time for business purposes (within state, out of state and/or internationally).

PREFERRED JOB REQUIREMENTS:

Education:

• None

Certification / Licensure:

• None

Work Experience:

• At least 2 years of supervisory/managerial experience preferred.
• Experience in Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products Industries preferred.

Knowledge / Skills / Abilities:

• None

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:

$116,000.00 - $174,000.00 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 roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click [here] https:/digital.alight.com/medline ;!!DjNdo6avjEs!o-bxZ6fy_WNH13q2FLYYmUMb1U4cic3ioox3ulm5dkpyivWM09cd64RN8rHuDH5AQKNiwEzHU2VbVJht5ginULSy5aJGsA$.

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 pagehere.

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.