Quality Assurance Associate II (hybrid)

Summary & Scope of Position:

Primarily responsible for assuring compliance with regulatory requirements (FDA, MDD, MDR) and ISO standards for Class III combination products. Provide GMP and ISO 13485 compliance support as necessary. Support a wide array of activities related to Supplier Management, NCs, CAPAs and SCARs.

Primary Responsibilities:

• Lead and track quality system deliverables to completion including NC/CAPA actions, internal audit findings, supplier audits, and actions from management reviews and data reviews.
• Manage internal and supplier audit schedules and documentation.
• Assist with the supplier management program, including supplier evaluations, performance monitoring, quality agreements, and audit tracking.
• Trend quality data and update Key Process Indicators. Participate in analysis of data to identify trends and recommend improvements to improve quality.
• Revise SOPs/INSs, route documents for approval, prepare flow charts and other quality documentation.
• Identify compliance weaknesses and ensure the implementation of workable solutions.
• Support documentation for product release.
• Perform other related duties as required.

Qualifications/Requirements/Skills:

• Bachelor's degree or equivalent in a scientific discipline
• Minimum of 2 years' quality assurance experience in a pharmaceutical or medical device industry.
• General understanding of the FDA GMP regulations and ISO 13485; EU MDR experience is a plus.
• Audit experience (quality audits, maintaining internal and supplier audit scheduling, or participating in root cause analysis and resolution of nonconformance or CAPAs).
• Supplier management experience (evaluating and monitoring supplier's performance; tracking, evaluating, and documenting supplier external certifications, participating in quality improvement projects related to supplier management).
• Ability to exercise independent judgment and problem-solving skills.
• Experience with documentation management systems and Enterprise Resource Planning (ERP) software is desired.
• Familiarity with quality data review and technical writing.
• Strong communication skills (encompasses verbal, written, interpersonal, listening).
• High level of attention to detail and accuracy.
• Flexible; ability to adapt to changing priorities.
• Excellent time management skills (schedules, timelines, task prioritization)

We understand that our people are essential to our success. This philosophy is revealed in our competitive benefits package, designed to improve employees' lives both on and off the job.

Benefits plans: medical, dental, vision, domestic partner benefits, paid maternity and paternity leaves, healthcare and dependent care flexible spending, life and accidental death insurance, long-term and short-term disability insurance, matching 401(k), ESPP, RSUs

Work and family: EAP, legal and financial services, health club membership discounts, tuition reimbursement

Compensation: The base salary range for this position in the selected city is $89,000-$124,000 annually. Compensation may vary outside of this range depending on various factors, including a candidate's qualifications, skills, competencies, experience, and location. Base pay is one part of the total package to compensate and recognize employees for their work.

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.