Quality Systems Compliance Specialist II

Patterson Companies, Inc.•Saint Paul, MN

2d•$68,300 - $88,767

About The Position

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 and supplier controls.

Requirements

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

Nice To Haves

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

Responsibilities

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
Performing QA supplier qualification activities including supplier assessment, supplier audit reviews, and author/review/approve and quality agreements
Author/review/approve and/or participate in supplier related risk assessments
Manage supplier change notifications including monitoring and quality assessments
Support supplier related change controls
Identify relevant Continuous Improvement opportunities of the Supplier Quality Management processes and systems based on performance monitoring, certification, auditing, supplier visits and other types of feedback.
Regularly report on Supplier Quality Performance (KPIs, action plans to improve poor quality performance, changes communicated from Suppliers, etc.)
Supports maintenance of and updates to the Approved Supplier List.
Prepare metrics and provide updates related to supplier quality
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