32 applicantsPosted by Agency
Planet Pharma ยท 3 days ago
Senior Quality Engineer
North Haven, CT
Contract
Onsite
Senior Level
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Hiring Manager
Heather Simyon McCracken
Insider Connection @Planet Pharma
Responsibilities
Lead PPAP qualifications with the CMs
Collaborate with CMs to develop robust SCAPAs
Support the Quality team to develop and improve an effective Supplier Quality process
Work with CMs/Suppliers to develop, implement, and maintain technical quality assurance systems
Collaborate on New Product Development (NPD) teams
Build and own the strategy for managing the CMs/Suppliers
Communicate with the business Quality lead on CM initiatives, updates, and issues
Partner with Supplier Quality Managers to build a strategy for managing the CMs in all regions
Ensure CM compliance with business Quality Systems
Facilitate customer complaints for CM products
Manage Supplier Corrective Action Request program
Develop, communicate, and manage a strategy/plan for addressing finished goods CMs/Suppliers capability deficiencies
Ensure proper approval and documentation practices are followed for any process, material or tooling change
Define and manage the process for growing effective partnerships with preferred CMs
Lead by Example in setting a continuous-improvement driven mentality and solid quality culture
Maintain compliance to set Key Performance Indicators
Manage and report on CMs/Suppliers audit program
Translate engineering, manufacturing, and quality requirements for CM products
Perform deviation investigations into quality issues
Manage qualifications of changes and co-ordinates associated change control activities
Evaluate CMs using the appropriate CM performance management processes
Responsible for ensuring effective up-to-date CM Quality Assurance documentation
Participate in annual supplier forums and business reviews
Qualification
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Required
Bachelor's degree in Engineering or related field
Minimum of 5 years of experience in Supplier Quality Management
Experience with PPAP qualifications
Experience with SCAPAs
Experience with MSAs, SPC, Quality Plans, Control Plans, and FMEAs
Experience in managing Supplier Corrective Action Request programs
Knowledge of ISO and/or FDA 21 CFR part 820 regulations
Strong communication and collaboration skills
Ability to lead and drive continuous improvement initiatives
Ability to evaluate and manage supplier performance
Experience in translating engineering, manufacturing, and quality requirements
Experience in conducting deviation investigations and change control activities
Experience in developing and maintaining quality assurance documentation and procedures
Preferred
Master's degree in Engineering or related field
Certification in Quality Management (e.g., CQM, CQE)
Experience in New Product Development (NPD)
Experience in managing supplier audit programs
Experience in conducting annual supplier forums and business reviews
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
Founded in 2009
1,001-5,000 employees
H1B Sponsorship
Planet Pharma 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
Trends of Total Sponsorships
2023 (1)
2022 (2)
2021 (8)
2020 (3)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase
