Quality Sys 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 and supplier controls.

A Day in the Life of a Quality Systems Compliance Specialist II:

• 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

Required Qualifications:

• 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

Preferred Qualifications:

• 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

This will be 2 days in the office hybrid model if a candidate lives within a commutable distance to Mendota Heights, MN or Loveland, CO.

The potential compensation range for this role is below. The final offer amount would be based on various factors such as candidate location (geographical labor market), experience, and skills. $66,600.00 - $81,600.00