Quality Assurance Specialist II

We Make Life More Rewarding and Dignified

Location: Nashville

Department: Quality

Summary

Support the facility Quality System to meet all regulatory compliance requirements, by handling procedures and records, supporting the preparation and implementation of audits and partnering with operations in achieving both facility and Global Quality objectives compatible with Hollister's Mission and Vision.

Responsibilities

* Support global compliance related projects as local DC representation and liaison for change control and impact communication

* Facilitate root cause investigations for all external complaints and internally raised quality related issues to coordinate corrective actions including roving audit findings

* Generate Certificates of Conformance and Certificate of Analysis

* Support efforts to maintain the Continuous Improvement methodology by attending daily tier meetings, routinely completing Gemba walks, supporting HPS element activities

* Support creation, revision, training for, and control of Standard Work documents

* Manage e-doc workflows for creation and revision of quality-controlled documentation to ensure facility procedures meet corporate guidelines, ISO and FDA requirements

* Manage LMS training curricula and perform associate training for quality procedures, GDP, and orientation

* Conduct internal audits to support the annual schedule

* Manage the calibration system and monitor the preventive maintenance system

* Support root cause investigation and action items for local CAPAs

* Participate as needed in regulatory audits e.g. ISO & MDSAP

* Participate as needed in supplier audits

* Ad hoc job related duties as determined and assigned by management

Essential Functions of the Role

• Good attention to detail
• Good report writing skills
• Team player
• Proficient Computer skills

Work Experience Requirements

• Number of Overall Years Necessary: 2-5

Education Requirements

• Minimum of a Bachelors degree in medical device engineering Pharma/ Food Science / Medical Device or other Technical Areas by education or experience.

Specialized Skills/Technical Knowledge

• Excellent communications skills
• Auditor Training - Preferred
• Basis technical writing skills
• Knowledge of ISO 13485 /GMP/GDP preferred

• The anticipated base pay range for this position is $65,000- $90,000. The actual salary varies based on applicant's location, education, experience, skills, abilities, and other legitimate business factors.
• If applicable: This position is also eligible for annual merit bonus increase target of 10%. The Company also provides a unique Benefit of Employee Share Ownership Program (BESOP) program based on earnings and length of service.
• The Company's health and welfare benefits include medical, prescription, dental, vision, spending/savings accounts, disability, company paid (parental and caregiver) leaves, statutory leaves/disability programs, accident, life, wellbeing, education assistance, adoption assistance, and voluntary benefit programs.
• The Company's 401(k) Retirement Savings Plan includes: auto-enrollment, ROTH, vesting and eligible participants "safe harbor" matching contributions.
• The Company's paid time off benefits include: 11 paid holidays, paid vacation based on length of service and exempt/non-exempt status, and sick days based on statutory requirements and/or exempt/non-exempt status.
• The Company's additional benefits include: education assistance and adoption assistance benefit programs.

EOE Statement

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

Job Req ID: 34406