Job Description

Nemera is a world leader in the design, development and manufacturing of drug delivery devices for the pharmaceutical, biotechnology and generic industries. We leverage a long-standing experience to provide our clients with leading-edge drug delivery devices for different application areas, from services, design to large scale manufacturing.

Job Description

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 objectives 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. 

• Effectively applies current methodology and enforces project standards by complying with project guidelines and company standards.

• Ensure that quality systems satisfy and always meet all customer specifications, internal and regulatory requirements (ISO, cGMP, FDA, Health and Safety Requirements). 

• Manage claims non-conformities, investigations, problem solving, root cause analysis, champion creation of effective and sustainable corrective actions. 

• Manage process and equipment Validation for new product and existing business.

• Train and develop the site Quality functional teams. 

• Define and implement quality initiatives to meet KPI’s and objectives.  

• Engage in customer and third-party visits and audits. 

• Identify opportunities for improvement through data trending and analysis, as well as develop and implement quality and inspection processes. Engage in risk assessment process; identification, data integrity, control and management utilizing risk assessment tools such as FMEA. 

• Manage Material Review Board activities to ensure proper disposition of internal rejections in a timely manner.   

• 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. 

• Review and approve various documents 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, ISO and third-party audits.

• Other duties as assigned

Qualifications

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 , medical device industry strongly preferred 

• 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, Process Validation, Equipment Validation, IQ/OQ/PQ , Automation and FMEA.

• 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, use, 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

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 

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.

We look forward to receiving your application (resume submitted in English is appreciated). We offer varied jobs job in an international group, if you want to discover more about Nemera, please look at our website

Know someone at Nemera? We have a Referral Program so, be sure to have them submit you as a referral prior to applying for this position!

 

POSITION RANGE: $115,000 - $175,000 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.)

For US Benefits, CLICK HERE .

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.

Job Tags

Full time, Work experience placement, Work at office, Shift work,

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