Senior Quality Compliance Specialist

Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

SUMMARY DESCRIPTION The Senior Quality Compliance Specialist has responsibility for supporting overall site Quality Management System (QMS) compliance. This position will support the Quality Compliance team and supports the site CAPA program, Quality Management Review preparation, Quality metrics, and the internal audit program. This position will support external audits in the capacity of backroom leadership and audit preparation. Works closely with all functional leaders to ensure on-going compliance and improvement.

ESSENTIAL DUTIES AND RESPONSIBILITIES To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Primary responsibilities are to:

Support the QMS processes and activities at the site.

Supports, and may lead, the development of new processes, standards, or plans in support of the organization’s strategies.

Prioritizes the completion of activities and projects to meet business needs.

Ensures ongoing site compliance to documented processes, current Good Manufacturing Practices, and applicable regulations / standards.

Support or lead Internal Audit Program, including conducting Internal Audits Support of CAPA process, including coordination of CAPA Review Board (CRB).This role requires experience in the back room of external audits, and preferably experience with FDA inspections.

Quality Management Review Coordination and preparation.

Quality Plan project management to ensure timely completion.

Support external audits including preparation and leadership/coordination of Backroom personnel and activities.

Leads or supports quality initiatives/projects as assigned.

Operates effectively with minimal supervision.

Other activities as assigned.

DESIRED MINIMUM QUALIFICATIONS The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

Bachelor’s degree in Engineering, Life Science, or a related field with 5+ years' experience in QA/Compliance within the medical device or similar industry or equivalent education and years of experience

Or Master’s degree with 3+ years of experience or equivalent education and years of experience

Or Doctoral degree with 0-2 years of experience or equivalent education and years of experience

Working knowledge of 21

CFR 820, 806, 803, Part 11, Part 4; ANVISA, TGA, Health Canada, EU, China & Japan regulations; ISO 13485, MDSAP, etc.

Previous experience with effective root cause investigation, corrective and preventive action planning, execution and verification of effectiveness techniques.

Experience with quality tools and process improvement techniques.

Experience as a Back room Lead during external audits (e.g., Notified Bodies and FDA).Exceptional quality system and regulatory documentation writing and editing skills (e.g., CAPA records, audit NC responses).Knowledge and direct experience with CAPA processes and records, including investigational techniques and CAPA boards.

Certified Quality Auditor is a plus.

Experience reviewing technical documentation.

Strong written and verbal communication skills

Strong critical thinking and analytical skills

Salary Pay Range:$81,650.00 - $ USD Salary Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit…