Establish relationships with DePuy Synthes sales, sales agents, commercial operations, supply chain, distribution and franchise customers to solve problems and meet changing operations and regulatory environments.
Define, implement, and validate quality system requirements and systems to meet departmental and business strategies.
Mentor and coach functional partners in the areas of GxP requirements.
Implement and improve systems/processes with focus on; customer and commercial quality, Inspection readiness, quality planning, nonconformance and corrective/preventive action plan development, implementation and effectiveness monitoring.
Provide quality support for existing and new distribution models & processes in the US.
Guide the Operations on the development of standard operating procedures.
Serve as single point of contact for assigned business partners.
Participate in, host and lead audits, inspections, investigations, and remediation activities.

Minimum Associates Degree or 3 years experience; (University degree in regulatory compliance or scientific field is preferred).
Proven experience in a regulated healthcare industry.
Experience in a fast paced, complex operation is required.
Ability to collaborate and communicate concepts in a way that is easily understood.
Self-directed with flexibility to work independently and on teams.
Time and project management skills.
Strong problem solving, root cause analysis and analytical experience.
Knowledge of applicable FDA regulations and ISO-13485 standards.
Preferred: Experience interacting with Health Authority or Notified Body is helpful.

Vacation –120 hours per calendar year
Sick time
40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time
up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
10 days Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year

Commercial Quality and Compliance Specialist

Key skills