Supplier Quality Manager

Job Description

Nemera is a global manufacturer of complex drug delivery systems for the pharmaceutical industry, offering a broad product portfolio that includes inhalation devices, injection devices, nasal and dermal pumps, and ophthalmic delivery devices.

• Plan, coordinate, and manage supplier quality evaluations through scheduling and auditing of suppliers.
• Interact with suppliers to ensure mutual interpretation of specified requirements and that 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 to maximize product quality and operating system efficiency.
• Identify and coordinate resolution of system inefficiencies that contribute to increased quality costs.
• Utilize CAPA problem solving techniques to reduce internal and external failures and assess results for application, validity, and conformance to specifications.
• Analyze supplier quality data and performance metrics.
• Oversee incoming inspection process and manage non-conformities related to supplied materials.
• Assist in maintaining ISO and FDA QMS quality system compliance.
• Generate and provide monthly reports.
• Execute specific responsibilities as defined within the company quality operating system.
• Support and maintain all company policies, including applicable FDA regulatory and ISO requirements, health and safety requirements, and continuous improvement initiatives.
• Suggest ways to improve the efficiency and safety of work and environment.
• Other duties as assigned.

• Bachelor’s degree in engineering, science, or related fields.
• Five or more years of experience in a quality position.
• Experience in the medical device industry preferred.
• Ability to apply advanced mathematical concepts and intermediate statistical knowledge.
• Ability to regularly lift up to 40 lbs with repetitive movements.
• Ability to push and pull items.
• Ability to stand and walk continuously during the shift.

• Formal quality certification (CQM, CQE).
• Leadership and strong interpersonal communication skills.
• Six Sigma Black Belt experience, training, and certification preferred.
• Three or more 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.

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

$100,000 - $125,000 USD

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.