Senior Quality and Compliance Specialist

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Develop, implement, and manage Quality and Compliance programs for the orthopedic last mile operations network across the United States.

• Assist both internal and external orthopedic last mile Field Inventory operations, Loaner Sites, and Distribution Centers in delivering field inventory and surgical loaner sets.

• Collaborate with Quality, Supply Chain, Delivery, Sales, and Commercial partners regarding distribution and commercial quality issues.

• Facilitate the prompt resolution of quality-related challenges and support enhancement opportunities that align with business goals and regulatory standards.

• Define, implement, and validate quality requirements and systems.

• Act as the primary point of contact for designated operations.

• Organize and lead audits, inspections, investigations, and remediation efforts.

• Ensure the Quality program adheres to regulatory compliance.

• Provide quality support for both existing and new distribution processes and go-to-market strategies.

• Develop, implement, and review standard operating procedures.

• Maintain relationships with orthopedic last mile operations and Franchise customers.

• Execute and enhance inspection readiness, process modifications, validation, calibration, preventive maintenance, and delivery service issue systems/processes.

• Investigate nonconformities and create, implement, and track corrective action plans to ensure their effectiveness.

• Coach and mentor other functional areas on ISO and cGMP standards.

⛳️ Requirements

• A Bachelor’s degree or an equivalent University degree is mandatory.

• 6–7 years of pertinent work experience in a regulated healthcare, medical device, pharmaceutical, consumer products, distribution, commercial quality, or quality systems environment.

• Familiarity with FDA regulations CFR 820, ISO 13485, ISO 9001, and quality system requirements applicable to medical devices, commercial distribution, and field inventory settings.

• Experience in supporting quality systems, document control, training compliance, quality metrics, audits, nonconformance management, corrective action processes, or similar compliance activities.

• Preferred experience with quality system IT platforms such as Windchill, ETQ, DMS, LMS, QEM, Summit, change control systems, ERP systems, warehouse management systems, or related tools.

• Ability to communicate and collaborate effectively with cross-functional partners.

• Adhere to established procedures, complete assigned tasks accurately and punctually, maintain organized records, and escalate issues when necessary.

• Employ critical thinking, problem-solving, and root cause analysis skills.

• Working knowledge of quality system requirements, good documentation practices, technical writing, Nonconformance, and CAPA.

• Proficiency in Microsoft Office, data analysis, and quality system applications.

• Preferred experience with Windchill, ETQ, Summit, ERP, or warehouse management systems.

• Preferred experience in audit preparation, inspection readiness, regulatory responses, or interactions with health authorities.

• Preferred certifications or training in Lean, Six Sigma, 5S, ASQ, ISO-13485, Good Distribution Practices, supplier quality, or other quality improvement methodologies.

🏝️ Benefits

• Retirement plan (pension).

• Savings plan (401(k)).

• Vacation – 120 hours per calendar year.

• Sick time – 40 hours per calendar year; 48 hours for employees residing in Colorado; 56 hours for employees residing in Washington.

• 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 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.

• Volunteer Leave – 32 hours per calendar year.

• Military Spouse Time-Off – 80 hours per calendar year.

• Inclusive interview process and accommodations for disabilities.

• Up to 25% domestic and international travel may be required.