APU Quality Manager

2 months ago

Buffalo Grove, United States NEMERA Full time

Nemera is a world leader in the design, development, and manufacturing of drug delivery devices for the pharmaceutical, biotechnology, & generics industries. With locations worldwide, some of our services and products include eyedroppers, pumps, valves, inhalation devices, airless dispensers, and auto-injectors.

Job Description

Position Purpose: Plan, coordinate and manage through completion, assigned projects designed to ensure continuous production and distribution of products consistent with established standards. Supervise and coordinate the activities of Quality staff. Evaluate compliance using relevant information and individual judgment to determine whether events or processes comply with specifications, operating procedures, and standards. Duties and responsibilities are accomplished personally or through subordinate staff.

KEY RESPONSIBILITIES/ESSENTIAL FUNCTIONS:

  • Coordinate and execute objectives throughout the company in cooperation with other managers, to maximize product quality and operating system efficiency/effectiveness to minimize costs

  • Identify and coordinate resolution of system(s) inefficiencies that contribute to increased quality costs

  • Coordinate the execution of validations, including creation of written protocols

  • Coordinate the execution and participates in elements of investigations regarding customer complaints

  • Assesses results of Customer Complaint investigations and Corrective Actions for application, validity, and conformance to FDA regulatory, ISO and Customer requirements

  • Ensures CAPA system is effective and utilizes problem solving techniques to reduce internal and external failures. Ensures sound techniques are applied (FMEA, Design of Experiments, Cause and Effect, Flow Charts, SPC) to solve problems effectively. Assesses results for application, validity, and conformance to specification

  • Analyzes data in relationship to assigned projects to determine adequacy of present standards and establish proposed quality improvements. This includes analysis of current inspection methods and sample plans.

  • Plans, promotes, performs, and organizes training activities for internal departments and customers, related to quality activities which include basic statistics, DOE, GR&R, Sample Plan designation, validation creation, control and oversight

  • Interacts with customers to assure mutual interpretation of specified requirements to ensure fulfillment of customer requirements and objectives are met

  • Ensures ISO and FDA QSR quality systems compliance

  • Generates and provides monthly and weekly reports as required

  • Executes specific responsibilities as defined within the company quality operating system

  • Supports and maintains all policies of the company including but not limited to applicable FDA regulatory and ISO requirements, Health and Safety Requirements and Continuous Improvement initiative

  • Review and approve various document as defined in the established QMS

  • Responsible for the coordination and evaluation of the Quality department

  • Carries out supervisory responsibilities, in accordance with the organization’s policies and applicable laws. Participates in interviewing, hiring, and training employees: planning assigning and directing tasks, apprising performance, rewording, and disciplining employees, addressing complaints, and resolving problems

  • Represent the Quality Department in support of customer and ISO audits

  • Other duties as assigned

POSITION REQUIREMENTS:

  • Bachelor’s degree in Engineering or related field

  • Minimum of 5 years of related work experience with at least one of those years in a supervisory role

  • Lean Manufacturing experience (including Six sigma training) and/or certifications preferred 

  • Database software such as SAP experience

  • Ability to lift 30 lbs., and stand / sit / walk up to 80% of shift

PREFERRED KNOWLEDGE/SKILLS:

  • Ability to apply advanced mathematical concepts and intermediate statistical knowledge

  • Excellent communication with the ability to understand, read, write, and speak English

  • Ability to coach and mentor on an individual and group basis

  • Demonstrated organizational skills with ability to meet strict deadlines daily

  • Ability to use common software productivity tools, such as Word, Excel, and PowerPoint

  • Ability to understand and articulate how individual role interrelates with Quality department function, goals, and objective

WORK ENVIRONMENT:

  • Office and clean room environment that may include moderate noise levels and required appropriate PPE and cleanroom apparel

  • Ability to travel between office and production departments as well as company buildings required

Qualifications

  • Bachelor’s degree in Engineering or related field

  • Minimum of 5 years of related work experience with at least one of those years in a supervisory role

  • Lean Manufacturing experience (including Six sigma training) and/or certifications preferred 

  • Database software such as SAP experience

  • Ability to lift 30 lbs., and stand / sit / walk up to 80% of shift

Additional Information

All your information will be kept confidential according to EEO guidelines.

Nemera is a world leader in the design, development, and manufacturing of drug delivery devices for the pharmaceutical, biotechnology, & generics industries. With locations worldwide, some of our services and products include eyedroppers, pumps, valves, inhalation devices, airless dispensers, and auto-injectors.

We put patients first when creating drug delivery devices because we know that accurate dosing and ergonomics contribute to patients completing their treatment. Working at Nemera means being part of a team that truly enjoys working together and always goes the extra mile to deliver on its commitments. We’re proud of the work we do because it improves patients’ lives.

Nemera is an equal opportunity employer and does not discriminate against any person on the basis of race, religion, color, gender, gender identity, sexual orientation, age, national origin, disability, veteran status, or any other protected class indication. This company is required by federal law to hire only persons who can establish they are eligible to work in the United States.

The Nemera timekeeping system utilizes finger scan. Our biometric policy is available upon request at bghr@nemera.net

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