Quality Sys Compliance Specialist II

Quality Systems Compliance Specialist II

Patterson isn't just a place to work; it's a partner that cares about your success. One of the distinguishing marks of our company is the talented people who embrace the people-first, always advancing, and results-driven culture. Professional growth abounds in this motivating environment. We value the diverse talents and experiences our employees bring to Patterson and believe that they build a stronger and successful organization.

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 :

Preferred Qualifications :

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.

We provide competitive benefits, unique incentive programs and rewards for our eligible employees :

The potential compensation range for this role is below. The final offer amount could exceed this range, based on various factors such as candidate location (geographical labor market), experience, and skills.

$66,600.00 - $81,600.00

EEO Statement

Patterson provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or other related medical conditions; status as a protected veteran or spouse / family member of a protected veteran; or disability.