Sr CAPA Engineer

Fresenius Medical Care; Atlanta (GA); On-site; USD 90,000 - 130,000; Full time

Job summary

Fresenius Medical Care is seeking a senior quality program leader to harmonize and standardize product transfer processes across regional/global areas. You will oversee quality at receiving sites and guide cross-functional teams through regulatory requirements and validation plans.

The role requires 6–8 years in quality, manufacturing or engineering within medical devices or pharma GMP environments, with strong collaboration skills and knowledge of FDA and MDR regulations.

Qualifications

• 6–8 years in Quality, Manufacturing and/or Engineering.
• Medical device/pharma GMP experience.
• Cross-functional collaboration proven.
• Knowledge of FDA, MDR/MDR regulations in medical devices/pharma.
• Engineering background required.
• Spanish language is a plus.

Responsibilities

• Lead harmonization and standardization of the product transfer process for the assigned regional/global area.
• Ensure product quality is achieved at the receiving manufacturing site during product transfer projects.
• Partner with CE quality, R&D, plant quality and manufacturing teams in transfers between sites.
• Ensure transfer projects comply with quality and regulatory requirements, with defined PFMEA, training, inspection and validation plans.
• Transfer reliable quality products into manufacturing through collaboration with value streams and operations.
• Develop receiving site quality metrics and oversee quality programs for transfers.
• Oversee and execute policies to ensure consistent outcomes and quality.
• Develop and implement quality and validation plans for new products at receiving facilities.
• Maintain compliance with FDA QSRs and ISO 13485.

Skills

Quality systems

Regulatory knowledge

Cross-functional collaboration

Medical devices

GMP environment

Project management

FDA regulations

Spanish language

Education

Bachelor's degree

Advanced degree desirable

Tools

PFMEA

Job description

PURPOSE AND SCOPE: Lead the harmonization and standardization of the product transfer process including execution and oversight of the product transfer process for assigned regional/global area.

PURPOSE AND SCOPE: Lead the harmonization and standardization of the product transfer process including execution and oversight of the product transfer process for assigned regional/global area.

PRINCIPAL DUTIES AND RESPONSIBILITIES

• Develop, implement, and maintain Global Product Transfer processes for design and manufacturing product transfer.
• Ensure product quality is achieved at the receiving manufacturing site level during product transfer projects
• Partner with CE vertical quality, R&D teams, plant quality and manufacturing teams (as appropriate) in the transfer of new products or site to site transfers between manufacturing sites.
• Ensure transfer projects comply with all quality and regulatory requirements, have clearly defined quality planning, including site registration, defined pfmea at receiving sites, training requirements established, inspections plans defined, validation plans developed and any other requirements as defined.
• Transfer reliable quality products into manufacturing through partnership with vertical value streams and manufacturing operations
• Assist in establishing receiving site quality metrics for a successful product transfer (example; capability, complaint rates, all quality deliverables achieved)
• Oversee and execute policies and procedures to ensure consistent outcomes
• Develop and execute quality and validation plans
• Deliver all required procedural updates associated with the addition of a new product at the receiving manufacturing facility
• Ensure all transfer activities are in compliance with the quality system, FDA QSRs and ISO 13485.
• Performs other related duties as assigned.

Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.

PHYSICAL DEMANDS AND WORKING CONDITIONS

The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• This position requires approximately 30% travel.

SUPERVISION

• None

EDUCATION AND REQUIRED CREDENTIALS

• Bachelor’s Degree; Advanced Degree desirable.

EXPERIENCE AND SKILLS

• 6 – 8 years’ of relevant experience in Quality, Manufacturing and/or Engineering discipline.
• Medical device, pharma or other regulated industry (automotive PPAP experience a plus)
• Engineering background
• Direct experience in design and/or manufacturing of medical devices/pharma in a GMP environment
• Proven track record in cross-functional collaboration
• Knowledge of FDA, MDD/MDR regulation in medical device and pharma
• Excellent communication skills with the ability to present and explain complex topics to multiple levels within the organization
• Demonstrated practice of continuous improvement and designing efficiency into processes
• Bilingual in Spanish- nice to have

ACKNOWLEDGEMENT

I acknowledge that I have read and accepted this job description. I understand what is expected of me in this position, and I am able to perform the essential functions as outlined with or without reasonable accommodation. Furthermore, I understand that the duties and responsibilities listed in this job description are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. If I have any questions about duties and responsibilities not specified in this job description that I am asked to perform, I should discuss them with my immediate supervisor or my Human Resources representative.

• Benefit Overview: This position offers a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave and potential for performance-based bonuses depending on company and individual performance.

Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws.

EOE, disability/veterans