Sr CAPA Engineer

Fresenius Medical Care; Waltham (MA); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Paid time off

Job summary

Fresenius Medical Care in Waltham, MA seeks a seasoned professional to lead global product transfer processes. You will harmonize transfer standards, ensure receiving-site quality, and drive cross-functional collaboration across CE quality, R&D and manufacturing.

The role requires 6–8 years in quality/manufacturing/engineering within regulated environments and strong GMP/regulatory knowledge. Travel up to 30% may be needed.

Qualifications

• 6–8 years of experience in Quality, Manufacturing or Engineering.
• Medical device/pharma regulated industry experience preferred.
• GMP environment experience is expected.
• Experience with FDA/MDD/MDR regulations is desirable.

Responsibilities

• Lead the harmonization and standardization of product transfer processes.
• Ensure product quality at receiving sites during transfers.
• Collaborate with CE quality, R&D, plant quality and manufacturing teams.
• Develop quality and validation plans and update procedures as needed.

Skills

Cross-functional collaboration

Communication skills

Continuous improvement

GMP/regulatory knowledge

Education

Bachelor's Degree

Advanced Degree desirable

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.

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

• 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.