Quality Engineering & NPI Manager

Quality Engineering & NPI Manager

Job Summary

Within the COPAN Diagnostics Quality Assurance and COPAN Italia Design and Development Departments, the Quality Engineering Program Manager(QEPM) will manage a Learn of quality assurance specialists and engineers and collaborate with cross-functional Learns to develop collection transport systems technologies and associated manufacturing workflows, while ensuring compliance throughout the product development life cycle by ISO 13485 : 2016 and ISO 9001 : 2015 as well as other applicable internal and external requirements.

The QEPM will provide leadership and oversight over contract manufacturing & support the Product Development department in new product design and development, following up related activities, cost & budgeting, communications to internal & external stakeholders, and other associated technical aspects of multiple projects.

Key Accountabilities

Manage a collection of projects and sub-projects covering quality engineering aspects and integrating product design and industrialization activities between Copan Diagnostic and Copan Italia.

Work cross-functionally with Product Design and Industrialization to, support in refining and finalizing the design, developing design requirements, testing of the design product development Process, DMR management, and Validation for industrialization ensuring that the production process, equipment, and systems are capable of consistently producing products that meet quality and performance standards.

Furthermore, plan and direct operational and project activities with accountability for the successful and compliant completion of assigned deliverables for business-to-business projects.

Manage the process related to changes involving all the affected departments (Copan Diagnostics and / or Copan Italia). change management.

It involves managing the process of changes that impact various departments, including both Copan Diagnostics and Copan Italia.

Drive the stability and ongoing improvement of production processes through strategic validation activities, ensuring the optimization of existing products and processes.

Lead site-level risk management and mitigation activities concerning program & project activities and timelines.

Assist in addressing customer complaints by participating in investigations to determine the underlying causes and developing solutions to improve customer satisfaction.

Furthermore, assess current customer requirements and search for areas of improvement.

Support activities related to management reviews, offering data and insights to help assess the overall performance of quality and compliance systems.

Assist in both internal and external audits to ensure that the organization's quality and compliance processes are in line with standards and regulations.

Provide routine status updates for health and risks of program and projects to internal and external stakeholders.

Required Skills and Abilities

• Experienced with regulatory requirements and quality standards applicable to the specific industry (e.g., ISO, FDA, cGMP)
• PKnowledge about the procedures related to the specific job position
• Attention to detailed to ensure compliance with established quality standard.
• Fluent in English, Bilingual in Spanish preferred
• Knowledge of ISO 13485 : 2016, ISO 9001 : 2015 and FDA 21 CFR 820 regulation
• Ability to multitask, prioritize, and critically think.
• Ability to solve problems and work collaboratively in a team environment.
• Proficiency with computer skills in a MS Word environment. Competent with MS Office : including Excel, Outlook, Word and PowerPointerforms other related duties as assigned by management.

Education and Experience

• Bachelors Degree
• 3 to 5 years of related experience

Physical and Travel Requirements

• Prolonged periods sitting at a desk and working on a computer.
• Must be able to lift up to 15 pounds at a time.

Travel between two sites Carlsbad and Murrieta CA