Quality Project Manager

Socket.dev; Buffalo Grove (IL); On-site; USD 120,000 - 140,000; Full time

Job summary

Nemera is seeking a Quality Project Manager to assure high quality products and services that satisfy customer and regulatory requirements. You will lead the Quality Department, drive CAPA activities, manage validations, and coordinate cross-functional teams to close gaps and improve process efficiency.

The role requires a Bachelor's degree in Engineering, 4+ years of manufacturing quality experience, and strong English communication. Travel between offices and production sites is expected.

Qualifications

• Bachelor’s degree in Engineering or related field is required.
• 4+ years of quality experience in manufacturing with supervisory experience.
• Strong communication skills in English.
• Knowledge of ISO, cGMP, FDA, and Health & Safety requirements.
• Experience with injection molding, automation, and FMEA.

Responsibilities

• Assist Associate Director of Quality in coordinating goals to improve product quality and efficiency.
• Direct and coordinate activities of Quality Department staff.
• Lead CAPA activities and drive root cause analyses.
• Manage process and equipment validations for new and existing products.
• Represent Quality in audits and ensure regulatory compliance.

Skills

Communication

Leadership

Problem solving

Teamwork

Attention to detail

Education

Bachelor’s degree in Engineering or related field

Tools

SAP

Excel

Database software

Job description

Position Purpose

The Quality Project Manager’s role is to assure high quality products and services that satisfy both internal and external requirements including meeting and exceeding customer expectations in compliance with regulatory requirements.

Key Responsibilities / Essential Functions

• Assists Associate Director of Quality in coordinating and executing goals and objectivess throughout the company to improve product quality and operating system efficiency.
• Direct and coordinate the activities of Quality Department employees.
• Establish and maintain sound relationships with production, technology, supply chain, quality teams and cross functional personnel to identify system and compliance gaps with proposed resolutions.
• Act as liaison with metrology, QC and compliance team
• Ensure adherence to project and company standards, while maintaining quality systems that meet customer, internal, and regulatory requirements (ISO, cGMP, FDA, Health & Safety).
• Manage claims non-conformities, investigations, problem solving, root cause analysis, champion creation of effective and sustainable corrective actions.
• Manage process and equipment Validations for new product and existing business.
• Change control process owner
• Define and implement quality initiatives to meet KPI’s and objectives.
• Identify opportunities for improvement through data trending and analysis, as well as develop and implement quality and inspection processes. Engage in risk assessment process; data integrity, control and management utilizing risk assessment tools such as FMEA.
• Review and approve technical protocols, reports, and specifications, as appropriate.
• Participate and lead CAPA activities as required, utilizing problem solving techniques to reduce internal and external failures.
• Employ necessary tools/resources and perspectives, treating all co-workers with respect/dignity and valuing feedback.
• Responsible for the coordination and evaluation of the Quality department.
• Supervises staff in line with company policies and laws, including hiring, training, task management, performance evaluation, discipline, and conflict resolution.
• Make hiring decisions for their direct reports.
• Represent the Quality Department in support of customer, ISO and third-party audits.
• Other duties as assigned

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

Position Requirements

• Bachelor’s degree in Engineering or related field
• 4+ years of relevant working experience in Quality in a manufacturing environment with 1+ year experience in a supervisory role
• Excellent communication skill with the ability to understand, read, write, and speak English
• Ability to apply advanced mathematical concepts and intermediate statistical (SPC) knowledge
• Strong understanding of injection molding, Automation and FMEA.
• Knowledgeable to equipment/process/product validation practices and principles.
• Excellent interpersonal, organizational and communication skills.
• Demonstrated leadership and the ability to motivate and influence others.
• Able to lift up to 30 lbs.
• Ability to push and pull items
• Ability to sit, stand, walk 80% of shift required

Preferred Knowledge/Skills

• Self-directed and possess knowledge of business and management principles involved in strategic planning, resource allocation and coordination of people and resources.
• Knowledge of inspection tools, including their design, repair and maintenance
• Medical device and/or Pharmaceutical Industry experience preferred
• Six sigma training and/or certifications preferred.
• Demonstrated organizational skills and general knowledge of PC applications such as Microsoft Word, Excel and Database software such as SAP

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

$120,000 - $140,000 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.

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.