RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, we also provide comprehensive clinical trial, lab and reimbursement services – reducing risk and supporting market access throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. RQM+ currently works for 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies.
The Quality Manager will oversee the implementation, maintenance and continuous improvement of the site Quality Management System(QMS) and Quality Metrics performance. You will work with site management and personnel to plan, develop, implement and continually improve site relevant QMS requirements, and to ensure sustainable compliance to customer, regulatory and QMS requirements. This role reports directly to the Head of Plant Operations, with a strong dotted-line report to the Platform Quality Lead within the business platform.
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, 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:, 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.
Requirements:
- Bachelor's degree, with a minimum of 5 years in relatable work experience required
- Minimum 2 years of supervisory experience
- Advanced training or experience in cGMPs, and ISO required
- Strong knowledge of PC systems, and MS Office Suite (Word, Excel) required
- Ability to understand and interpret federal regulations and company operating procedures as they apply to printing regulated product and quality issues
- Must be able to prioritize and multi-task with minimal supervision
- Excellent written and verbal communication skills
Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today!
We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.
Job Opportunity Verification
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All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careers
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