Supplier Quality Manager

Nemera France SAS; Buffalo Grove (IL); On-site; USD 100,000 - 125,000; Full time

Job summary

Nemera France SAS is seeking a Supplier Quality Manager to plan, coordinate, and manage supplier evaluations and quality agreements to sustain production quality. The role collaborates with procurement, engineering, manufacturing and suppliers to reduce risk and drive continuous improvement across the supply chain.

Candidates should have a Bachelor's in Engineering or related field, 5+ years in quality, and experience in the medical device sector; Six-Sigma certification and SAP/Microsoft Office

Qualifications

• Bachelor's degree in engineering, science or related field required.
• 5+ years of experience in a quality position.
• Experience in medical device industry preferred.
• Advanced mathematical concepts and statistics knowledge helpful.
• Ability to lift up to 40 lbs and stand/walk during shift.

Responsibilities

• Plan, coordinate, and manage supplier quality evaluations through scheduling and auditing of suppliers.
• Interact with suppliers to ensure mutual interpretation of requirements and meet customer objectives.
• Evaluate compliance using relevant information to determine conformity to specifications.
• Support implementation and management of quality agreements with all suppliers.
• Work with Supply Chain and Procurement to evaluate and manage supplier performance.
• Identify and complete continuous improvement projects using Six Sigma tools.
• Assist the Plant Quality Manager to maximize product quality and efficiency.
• Identify and coordinate resolution of system inefficiencies that increase quality costs.
• Utilize CAPA techniques to reduce internal and external failures and assess results.
• Analyze supplier quality data and performance metrics.
• Oversee Incoming Inspection and manage non-conformities related to supplied materials.
• Assist in maintaining ISO and FDA QMSR compliance.
• Generate and provide monthly reports.
• Execute responsibilities within the quality operating system.
• Support and maintain company policies including FDA/ISO requirements.

Skills

Six Sigma

Leadership

Intrapersonal communication

Supervisory experience

Independent worker

Education

Bachelor's Degree in Engineering, Science or related fields

Six-Sigma Black Belt

Tools

SAP

Microsoft Office

Job description

With sales of €700m and 3,300 employees worldwide, Nemera is one of the leading global manufacturers of complex drug delivery systems for the pharmaceutical industry, offering to patients a broad product portfolio which includes inhalation devices, injection devices, nasal and dermal pumps and ophthalmic delivery devices. Nemera has built very long lasting, strong relationships with the leading global pharmaceutical companies globally by providing high quality development, industrialization and manufacturing services. Nemera develops and manufactures its own IP product platforms but also offers also fully custom developments and contract manufacturing.

Nemera’s manufacturing sites are located in the US, France, Germany, Brazil and Poland. The headquarters and Innovation Center for early device design and development are located in France (Lyon).

We have big ambitions at Nemera! We are growing our franchises and strengthening our capabilities.

Job Description

The Supplier Quality Manager is responsible for planning, coordinating and managing all assigned projects and audits to ensure supplier qualification and routine performance and maintain continuous production and distribution of products consistent with established Quality standards. This role works closely with procurement, engineering, manufacturing, and suppliers to improve product quality and reduce risks in the supply chain.

KEY RESPONSIBILITIES/ESSENTIAL FUNCTIONS

• Plan, coordinate, and manage Supplier Quality evaluations through scheduling and auditing of suppliers
• Interact with suppliers and ensure mutual interpretation of specified requirements to make certain customer requirements and objectives are met
• Evaluate compliance using relevant information and individual judgment to determine whether events or processes comply with specifications, operating procedures, or standards
• Support implementation and management of quality agreements with all suppliers
• Work with Supply Chain and Procurement to evaluate and manage supplier performance
• Identify and complete continuous improvement projects utilizing Six Sigma tools and methodologies
• Assist the Plant Quality Manager in coordinating and executing objectives throughout the company in cooperation with other managers, to maximize product quality and operating system efficiency and effectiveness to minimize costs
• Identify and coordinate resolution of system inefficiencies that contribute to increased quality costs
• Utilize CAPA problem solving techniques to reduce internal and external failures, select sound techniques (FMEA, Design of Experiments, Cause and Effect, Flow Charts, SPC) to solve problems effectively, and assess results for application, validity, and conformance to specifications
• Analyze supplier quality data and performance metrics
• Oversee Incoming Inspection process and responsible for managing non-conformities related to supplied materials
• Assist in maintaining ISO and FDA QMSR quality system compliance
• Generate and provide monthly reports
• Execute specific responsibilities as defined within the company quality operating system
• Support and maintain all policies of the company, including but not limited to applicable FDA regulatory and ISO requirements, Health and Safety Requirements and Continuous Improvement initiatives
• Suggest ways to improve the efficiency and safety of our work and environment
• Other duties as assigned

Qualifications

POSITION REQUIREMENTS:

• Bachelor’s Degree in Engineering, Science or related fields required
• Must have 5 or more years of experience in a Quality position
• Experience in the Medical Device industry preferred
• Must have ability to apply advance mathematical concepts and intermediate statistical knowledge
• Ability to regularly lift up to 40lbs with repetitive movements
• Ability to push and pull items
• Ability to stand and/or walk up to constantly during the shift

PREFERRED KNOWLEDGE/SKILLS:

• Formal Quality certification (CQM, CQE)
• Leadership and good intrapersonal communication skills
• Six-sigma black belt experience, training, and certification preferred
• 3+ years of supervisory experience in a similar environment strongly preferred
• Computer skills including Microsoft Office application and SAP experience
• Ability to work independently from verbal and/or written instructions
• Ability to understand and articulate how individual role and responsibilities tie into Quality department objectives

WORK ENVIRONMENT

• Works in a clean manufacturing environment that may include moderate noise levels and required appropriate cleanroom apparel
• Up to 40% travel required

ADDITIONAL NOTES

This Job Description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee and may be revised at any time by the Company.

Additional Information

Why Join Nemera?

At Nemera, we prioritize patients when creating drug delivery devices, understanding that accurate dosing and ergonomics are crucial for treatment adherence. Joining Nemera means becoming part of a team that enjoys working together and consistently delivers on its commitments. We take pride in our work because it improves patients’ lives.

POSITION RANGE

$100,000- $125,000 USD Salaried (This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.)

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.