Compliance Manager

CH01 CHE Fresenius Medical Care (Schweiz) AG; Waltham (MA); On-site; USD 109,000 - 183,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Paid time off

Job summary

Fresenius Medical Care (Schweiz) AG is seeking a senior quality systems leader in the United States with extensive regulatory expertise. You will oversee tactical execution of quality objectives, coach staff, and collaborate with HR on personnel matters while ensuring conformity with applicable government and company standards.

The role requires strong attention to detail and the ability to drive results across multiple teams.

Qualifications

• Bachelor's degree in a scientific or engineering discipline is required.
• 6–8 years of related quality systems experience in medical devices/pharma.
• Strong attention to detail and ability to drive results.
• Excellent written and verbal communication; capable of training staff.

Responsibilities

• Lead tactical execution of quality systems objectives and staffing.
• Provide coaching and development plans for direct reports.
• Develop and implement standards, methods, and procedures for QA.
• Report quality metrics to senior management as needed.

Skills

Quality systems leadership

Regulatory compliance

US cGMP/QSR knowledge

FDA regulatory requirements

ISO 13485 knowledge

Supervisory experience

Microsoft Office proficiency

Education

Bachelor's degree in science or engineering

Advanced degree desirable

Job description

PURPOSE AND SCOPE

Develops, implements, and maintains the activities of company quality systems. Manages and oversees the activities of various levels of quality systems staff.

PRINCIPAL DUTIES AND RESPONSIBILITIES

Manages the tactical execution of short- and long-term quality systems objectives through the coordination of activities with a direct responsibility for results, including costs, methods, and staffing. Provides leadership, coaching, and development plans for all direct reports to maintain an engaged and productive workforce; partnering with Human Resources on employee matters. Provides technical guidance. Technically proficient in the specific quality systems department and knowledgeable 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. Oversees development and implementation of standards, methods, and procedures for inspecting, testing, and evaluating the precision, accuracy, and reliability of company products. Makes recommendations for corrective action necessary to ensure conformity with quality specifications. Ensures finished products conform to government and company standards and satisfy good manufacturing practices regulations. Selects, develops and evaluates personnel to ensure the efficient operation of the function. Collaborates with internal and/or external resources to resolve problems of medium to high complexity in Quality issues. May report quality metrics to senior/executive management, as needed. In some locations/sites, may have the authority to issue a STOP NOTICE to immediately stop production when a concern regarding possible productions, stocking, or shipping of discrepant assemblies or product arises. Represents functional expertise at relevant department and site meetings, as needed. 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). Makes recommendations for process improvements and participates in planning and implementing changes. 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. 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. Assists with various projects as assigned. Other 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. Works in an office environment and may be required to perform light lifting. This position involves sitting and or walking for considerable lengths of time. Bending to floor level is required. Travel up to 10% of the time required with the potential for additional travel, as needed.

SUPERVISION

Responsible for the direct supervision of various levels of quality systems staff.

EDUCATION

Bachelor's Degree required, preferably in a scientific or engineering discipline; Advanced Degree desirable.

EXPERIENCE AND REQUIRED SKILLS

Minimum 6 - 8 years of related quality systems experience in a medical device/pharmaceutical environment. 3+ years of supervisory experience preferred. Must be proficient with personal computer; strong skills with Microsoft Office software. Knowledge in relevant federal regulatory requirements. Strong attention to detail. Ability to drive results. Ability to train technical, professional, and managerial level personnel. Excellent verbal and written communication and strong interpersonal skills. Requires ability to function effectively in multiple team settings as well as independently and to manage multiple priorities. Knowledge of US cGMP/QSR, ISO 13485, and related Quality standards. Strong knowledge of FDA regulatory requirements and of standard quality assurance practices for manufacturing operations. As applicable, strong knowledge of Health Canada GMPs. Remains current with industry standards and best practices.

ANNUAL RATE

The rate of pay for this position will depend on the successful candidate’s work location and qualifications, including relevant education, work experience, skills, and competencies. Annual Rate: $109,000.00 - $183,000.00 Non-Bonus Eligible Positions: include language below. 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.

BONUS-ELIGIBLE POSITIONS

Bonus Eligible Positions – include language below. 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

Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws. Fresenius Medical Care is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sexual orientation, gender identity, parental status, national origin, age, disability, military service, or other non-merit-based factors Creating a future worth living. For patients. Worldwide. Every day. Fresenius Medical Care is the world's leading provider of products and services for individuals with kidney disease of which approximately 4.5 million patients worldwide regularly undergo dialysis treatment. United by a shared purpose of creating a future worth living for chronically and critically ill people, we care for around 292,000 dialysis patients around the globe. In addition, we operate around 35 global production sites to provide products such as dialysis machines, dialyzers, and related disposables. We aim to continuously improve our patients’ quality of life by offering them high-quality products as well as innovative technologies and treatment concepts.