Job Summary
Responsible for managing the quality and compliance for applicable products and processes for assigned area(s). Assume responsibility for a subset of individual projects that support the division and/or manufacturing area, compliance, new product development per the needs of the team.
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.
- Responsible for building and maintaining appropriate product documentation (e.g. Device Master Records, Design Controls, Risk Management, and CE Technical Files) in compliance with applicable regulations.
- Work with Regulatory Groups and Suppliers to produce 510K submissions, letters to file, etc., as required.
- Acts as a liaison with the Divisions, Suppliers, Manufacturing, and/or Operations to ensure quality products and customer satisfaction.
- Help in complaint trend investigations and develop new approaches to solve problems identified during the investigation process.
- Identify, implement 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, inspection, process validations, and coordinate testing 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.
- Lead investigations of product and process non-conformances and out-of-specification results and collaborate with supplier representatives, as needed, to develop effective corrective and preventive actions (CAPA, SCAR).
Management responsibilities:
- Typically manages teams of 2-3 employees, depending on the workload and the required level of involvement with direct reports. Teams may include QCs, QA/Sr QA Technicians, AQS, AQE, QS, and QE;
- Oversees day-to-day operations of a group of employees.
- May have limited budgetary responsibility and usually contributes to budgetary impact.
- Interprets and executes policies for departments/projects and develops them.
- Recommends and implements new policies or modifications to existing policies.
- Provides general guidelines and parameters for staff functioning.
- Plays a key role in hiring staff, recommending pay increases, conducting performance reviews, training and developing staff, estimating personnel needs, assigning work, meeting completion dates, and interpreting and ensuring consistent application of organizational policies.
MINIMUM JOB REQUIREMENTS:Education
- A Bachelor’s degree in Engineering, Science, Math, or a related field is usually required, or equivalent experience.
Work Experience
- At least 3 years Quality Engineering experience.
Knowledge / Skills / Abilities
- Working knowledge of government and industry quality assurance codes and standards (e.g. 21 CFR 820, ISO13485).
- Experience analyzing and reporting data in order to identify issues, trends, or exceptions to drive improvement of results and find solutions.
- Experience controlling and coordinating concurrent projects, competing priorities and critical deadlines.
- Experience leading teams to accomplish cross-functional goals.
- Experience using time management skills to prioritize, organize, and track details in order to meet deadlines of multiple projects.
- Experience using MS Office Suite products (Word, Excel, PowerPoint, Outlook); including intermediate skill Level in Microsoft Excel (for example: conditional formatting, tables, formulas, charting).
- Position requires travel up to 25% of the time for business purposes (within state, out of state and/or internationally).
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:
$101,000.00 - $152,000.00 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 .
