Quality Assurance Coordinator - Medica Device

Socket.dev; Tennessee; On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Competitive compensation

Paid time off

Healthcare benefits

Job summary

Crown Aesthetics is seeking a Quality Assurance Coordinator to support the QMS and drive improvement across product quality and corporate goals. The role conducts batch release reviews, quality system assessments, and continuous improvement activities under FDA/ISO/cGMP guidelines.

Reporting to the QA Manager - Medical Device, the position is located at the Plant with standard hours Mon-Fri. Strong auditing and leadership capabilities are essential to ensure compliance and effective quality

Qualifications

• Knowledge of FDA, ISO, cGMP regulations and requirements.
• BS degree in life science or engineering; work experience may substitute.
• Lean Six Sigma Green or Black Belt certification preferred.
• Understanding of quality audit process; internal auditor certification preferred.
• Familiarity with KPI and metric development and tracking.
• Minimum of 2 years’ experience in a manufacturing or quality assurance role in a highly regulated industry.
• Strong interpersonal communication and meeting management skills.
• Excellent organization and PC skills.
• Ability to work independently while demonstrating leadership and integrity.

Responsibilities

• Perform thorough QA Review of incoming and kitting batch records prior to release.
• Ensure QC Testing is completed and in place prior to batch release.
• Review Quality System for open NCMs and CAPAs related to batch release.
• Initiate, monitor, and review NCM and CAPA.
• Support risk assessments and failure mode investigations.
• Assist with KPI and metric generation.
• Collect data for continuous improvement and provide recommendations.
• Provide support and direction for quality related topics.

Skills

FDA/ISO/cGMP knowledge

Lean Six Sigma

KPI & metrics tracking

Internal auditing

Interpersonal skills

Organization and PC skills

Independent leadership

QA experience

Education

BS degree in life science or engineering

Job description

Job Summary:

The Quality Assurance Coordinator supports multiple functions within the Crown Aesthetics organization by ensuring goals and priorities for assigned quality and business-related functions are met. This position will focus on the quality management system (QMS) and be responsible for establishing opportunities that promote growth, improvement, and compliance for product quality and corporate goals. The primary responsibilities of this role will include, but are not limited to, quality system support, documentation authoring and upkeep, Review of individual batch records to ensure their compliance with all Crown Aesthetics & Therapeutics Kitting SOPS and in compliance with FDA -CFR 210, 820 and ISO13485 standards (as applicable), participating and conducting continuous improvement initiatives (metric tracking and trending).

Reporting to:

QA Manager - Medical Device

Location:

Plant

Hours:

Monday - Friday: 8:00am - 4:30pm

Responsibilities/Essential Duties:

• Perform thorough QA Review of individual incoming & kitting batch records prior to their release.
• Ensure that all QC Testing is complete and in place prior to batch release.
• Perform a review of Quality System for any open NCMs and CAPAs that may be related to the batch prior to release.
• Initiation, monitoring, and review NCM and CAPA.
• Support risk assessments and failure mode investigations.
• Assist with KPI and metric generation.
• Continuous improvement data collection and recommendations.
• Provides support and direction for quality related topics.
• Ensures company’s adherence to cGMP, procedural requirements, and client specifications
• Assist with internal and external certification audits
• On-going monitoring of sterilization BI information from routine loads, environmental & bioburden audit info
• Additional responsibilities will be assigned as necessary
• Assist supplier quality with supplier monitoring
• Maintain ongoing training and competency in assigned job function
• Assist in the training and development of QA Specialists

Qualifications:

• Strong understanding of the FDA, ISO, cGMP, etc., regulations and requirements
• Preferer a BS degree in a life science or engineering discipline (work experience may be considered in lieu of degree)
• Experience with Lean and Six-Sigma methodologies — Green or Black Belt certification preferred
• Understanding of quality audit process – internal auditor certification preferred
• Familiarity with KPI and metric development and tracking
• Minimum of 2 years’ experience, in a manufacturing or quality assurance role, in a highly regulated industry (medical device or pharmaceutical) preferred
• Successful interpersonal communication and meeting management skills
• Excellent organization and PC skills
• Must be able to work independently while demonstrating leadership and integrity qualities

Working Conditions:

• No requirements or restrictions.

Company Summary:

Crown is a proud member of the Revance Portfolio of skincare offerings. Revance is a fast-growing global aesthetics and skincare company focused on providing innovative aesthetics and market-leading skincare offerings throughout every stage of life. With a differentiated portfolio of products spanning 60 countries, Revance meets the evolving needs of patients and consumers worldwide through continued innovation and commercialization of new products and treatments.

What Revance invests in you:

• Competitive Compensation including base salary and annual performance bonus
• Paid time off, holidays, and floating holidays that can be used for whatever you choose
• Generous healthcare benefits, Employer HSA match, 401k match, wellness discounts and much more

This section of the job description is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a “qualified individual with a disability” in all aspects of the employment relationship. A “qualified individual with a disability” is “an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job.”

Revance is an Equal Opportunity employer. All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.