Quality Systems Compliance Specialist II
The Quality Systems Compliance Specialist II is responsible for maintaining and managing the daily operations of the Patterson Quality Management System. Manages compliance activities with responsibility for results in terms of ongoing effectiveness of the QMS and of conformance to applicable regulation, standard and company policies. Supports activities related to design history, risk management, supplier controls and regulatory registrations and submissions.
- Oversees daily operations of the QMS for compliance to requirements of applicable regulation and standard, including 21 CFR Part 820, ISO 13485 and others as applicable
- Proposes and implements improvements to the QMS and its procedures and processes to maintain ongoing effectiveness
- Manages Corrective and Preventive Action (CAPA) and Supplier CAPA records from initial investigation and root cause analysis, into action planning and effectiveness in a timely and compliant manner
- Manages complaint review, investigation and reporting in a timely and effective manner
- Manages field action risk assessment, bounding, inventory control, communications, effectiveness checks and reporting/closure
- Manages controlled documents and records including but not limited to design history, risk and supplier files; responsible for organization and retention of electronic/paper documents and records related to QMS
- Develops and coordinates management review and generates quality system metrics in support of management review
- Coordinates audit schedule and participates in internal/external audits and may lead supplier audits
- Assists with regulatory submissions, registrations and licensing applications as applicable
- Helps to interpret and apply regulatory and quality requirements; uses a risk-based approach to enable effective decision-making
- Stays current on industry trends in relation to compliance
- Provides support and contributes to other compliance activities and areas as necessary
- Other duties as assigned
- Occasional travel required
- Bachelors Degree in Engineering, Science or related field or equivalent work experience
- 2-4 years’ experience with quality management systems and regulatory compliance in the medical device or related regulated field
- Developing working knowledge of quality management systems and regulatory submission requirements, preferably in an FDA-regulated environment (FDA 21 CFR Part 820 and ISO 13485 requirements)
- Demonstrated ability to review and quickly assimilate complex regulatory compliance information and standards
- Ability to work effectively within a team and as an individual contributor in a fast-paced changing environment -- multi-tasks, prioritizes and meets deadlines in timely manner
- Strong verbal and written communications with ability to effectively communicate at specialist and line management levels in the organization
- Strong organizational, analytical, and creative problem-solving skills and track record contributing to team work practices with a moderate impact on functional objectives
- Highly self-motivated and directed and able to carry out responsibilities with latitude and limited supervision
- Ability to prioritize and execute tasks in a high-pressure environment
- Strong customer service orientation
- Experience working in a team-oriented, collaborative environment
- Experience working in the Microsoft Office Suite
- 2+ years of Supplier evaluation, qualification, monitoring and CAPA experience
- 2+ years of Distribution controls experience
- Some experience with Design Controls, specifically labeling and shipping packaging is a plus
What's In It For You:
We provide competitive benefits, unique incentive programs and rewards for our eligible employees:
- Full Medical, Dental, and Vision benefits and an integrated Wellness Program.
- 401(k) Match Retirement Savings Plan.
- Employee Stock Purchase Plan (ESPP).
- Paid Time Off (PTO).
- Holiday Pay & Floating Holidays.
- Volunteer Time Off (VTO).
- Educational Assistance Program (Tuition Reimbursement).
- Full Paid Paternity and Adoption Leave.
- LifeWorks (Employee Assistance Program).
- Company-Paid Short-Term Disability.
- Patterson Perks Program.
Please click herefor an overview of benefits offered!
As a people-first company, Patterson promotes a culture that embodies and celebrates diversity and inclusivity. We believe our employees’ unique experiences and differences are what strengthen us and drive our success. We consider all qualified applicants without regard to race, religion, color, sex, national origin, age, sexual orientation, gender identity, disability or veteran status.
We are Patterson. We welcome you.