Manager - Quality Assurance jobs in United States
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RR Donnelley · 5 hours ago

Manager - Quality Assurance

RRD is a leading global provider of marketing, packaging, print, and supply chain solutions that elevate engagement across the complete customer journey. They are seeking a Manager, Quality Assurance to oversee and advance their quality systems and standards, ensuring compliance with customer and regulatory requirements.

Marketing & Advertising
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H1B Sponsor Likelynote

Responsibilities

Provides ongoing leadership and support in maintaining and continually improving of site Quality Management System (QMS) and processes inclusive of food safety / contact & Medical Device / Pharma GMP’s, as required
Ensures that site QMS is in compliance with RRD QMS requirements, including Quality Task Tracker and Quality Metrics reporting
Coordinates activities to maintain relevant Quality System requirements such as ISO 9001:2008, GMP (21 CFR Part 820), etc., including preparing for and scheduling annual certification compliance audits
Informs site Management of significant or potentially significant quality issues, and facilitates effective root cause analysis and corrective/preventive actions to reduce or eliminate errors
Monitors and measures trends in QMS processes, including GMP Quality Metrics
Evaluates the effectiveness of relevant site QMS processes (such as ISO 9001:2008, GMP (21 CFR Part 820)) through internal audits and the evaluation of site Quality Metrics data
Collects and submits quality task tracker and quality metrics data for the site, on a monthly basis, and issues a report to the Platform Quality Lead
Interacts with customers and assists with quality related responses to RFP’s/RFI’s for the site
Reviews relevant GMP documents for compliance to company SOPs, quality systems, and regulatory requirements
Leads and manages ongoing internal process verification audits throughout year
Provides leadership and direction to quality department employees
Ensures all deviation investigations are appropriately investigated and recorded
Drives CAPA items to complete and timely completion
Participates in other activities, as deemed appropriate

Qualification

Quality Management SystemCGMPISO 9001ISO 13485JD EdwardsMicrosoft Office SuiteManagement skillsCommunication skills

Required

Minimum: 4 Year / Bachelors Degree in Related Field
Minimum 5+ years related work experience including a minimum of 2 years of supervisory experience
Advanced training or experience in cGMPs, and ISO required
Ability to understand and interpret federal regulations and company operating procedures as they apply to printing regulated product and quality issue
Must be able to prioritize and multi-task with minimal supervision
Knowledge of PC systems and Microsoft Office Suite (Word, Excel) required
Excellent written and verbal communication skills
Strong management and communication skills
Skills to make presentations to top management
Broad understanding of manufacturing processes

Preferred

Graduate Degree
JD Edwards or an ERP system experience is a plus
Certification in ISO 9001 & 13485 desirable

Benefits

Medical
Dental
Vision coverage
Paid time off
Disability insurance
401(k) with match
Life insurance
Other voluntary supplemental insurance coverages
Tuition assistance
Maternity leave
Adoption assistance
Employer/partner discounts

Company

RR Donnelley

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RRD provides a complete portfolio of marketing, packaging, print and business services to the world’s most respected brands, including 91% of the Fortune 100.

H1B Sponsorship

RR Donnelley has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (2)
2023 (16)
2022 (14)
2021 (6)
2020 (14)

Funding

Current Stage
Late Stage

Leadership Team

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Tom Quinlan
President & Chief Executive Officer
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Drew Coxhead
Chief Financial Officer
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Company data provided by crunchbase