Manager, Software Quality Engineer - Fresenius Medical Care Holdings, Inc.

PURPOSE AND SCOPE:

The Manager, Software Quality Engineering is responsible for ensuring all GxP Computer Systems follow Corporate CSV policies and procedures. This role will have both managerial and operational responsibilities in the deployment and enforcement of FMC RTG Software Quality policies, procedures and templates.  The position will lead a small team of validation engineers to manage, establish, implement and organize Software Quality activities for identified Computer systems. This position will manage and mentor a group of validation engineers both internal and external resources and will be providing the business support during internal and external audits of computerized systems.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Interpret companywide policies and procedures, regulatory standards and industry standards for all CSV related validation process.
• Partner with internal and external colleagues to influence or plan and execute computer system validation strategies for implementation.
• Provide expertise and guidance in interpreting regulations to ensure compliance.
• Provide leadership, coaching and development plans for all direct reports to maintain an engaged and productive workforce; partnering with Human Resources on employee matters.
• Technically proficient in product lifecycle management (PLM) software and knowledge of industry practice and business principles.  Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends. 
• Follow methods for monitoring the compliance of software system processes, standards and procedures.
• Assist in inspections of FMCNA by regulatory authorities.
• Exercise effective resource allocations, manages resources and capacity analysis and oversees training requirements for direct reports.
• Follows processes and operational policies in selecting methods and techniques for obtaining solutions.  Interprets and recommends change to policies and establishes procedures that effect immediate organization(s).
• Frequently interacts with subordinate supervisors, customers, and/or functional peer group managers, normally involving matters between functional areas, other company divisions or units, or customers.
• Participates and presents at meetings with internal and external representatives. Often leading a cooperative effort among members of a project team.
• Interacts with internal departments and external customers; particularly in problem resolution.  Acts as an advisor to subordinate(s) to meet schedules and/or resolve technical problems.  Responsible for hiring, coaching and counseling employees, including performance reviews, disciplinary action and terminations.
• Provide technical guidance.
• Assist with various projects as assigned.
• Other duties as assigned.

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. 

SUPERVISION:

• .Leads and directly manages a small team of Validation Engineers

EDUCATION:

• Bachelor's Degree required; Advanced Degree desirable

EXPERIENCE AND REQUIRED SKILLS:

• 10-12 years of related experience in Software Engineering, Information Technology or Software Quality Assurance in a regulated environment, or a Master's degree with 6 years of related experience.
• 2+ years of management experience preferred managing validation activities
• Strong understanding of CFR title 21 (parts 11,210, 211  and 820), GAMP 5 and e-records/e-signature standards and guidance.
• Experience and proficiency with industry standard enterprise systems (Windchill, SAP).
• Very strong analytical and problem solving skills.
• Excellent attention to details, resourceful, self-reliant, self-motivated and confident.
• Ability to interact with all levels in the organization

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

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

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

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