Planet Pharma ยท 22 hours ago
Sr. Quality Assurance Engineer
Woburn, MA
Full-time
Onsite
Senior Level
$55/hr - $80/hr
5+ years expPlanet Pharma is seeking a Senior Quality Assurance Engineer to provide Quality Engineering support for design control and risk management deliverables associated with medical devices. The role involves ensuring compliance with global regulations and supporting manufacturing and supplier activities.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Serve as Quality Engineering representative ensuring that design and manufacturing related activities are completed and comply with global medical device regulations (e.g., FDA, EU, etc.) and Quality System requirements
Generate and ensure compliant completion of Quality deliverables such as Design Reviews, Engineering Change Orders, Design & Development Plan, Risk Management, User Needs, Design Input Requirements, Test Methods, Design Review, Design V&V, Usability Testing, SW Validation, Process Validation, Packaging, Labeling, Statistical sampling plans, etc
Provide Quality Engineering support in as part of supplier qualification, audit, ongoing monitoring, and supplier improvement activities
Develop and deploy Quality System related processes, tools, training, and metrics to enabling us to meet business needs and comply and global medical device regulations
Serve as Subject Matter Expert on Design Controls and Risk Management medical device regulatory requirements
Lead CAPA, post market surveillance and other quality improvement efforts
Provide key quality trending information and data for use in periodic reviews
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE)
Qualification
Required
BS in STEM (Science, Technology, Engineering, Mathematics)
5+ years Quality Engineering design controls/risk management experience within Medical Device industry for companies with greater than $1bn USD annual revenue
Demonstrated competency with the 21 CFR, 820, Medical Device Directive, EN ISO 13485, and EN ISO 14971, particularly with respect to product design & development and product risk management
Familiarity with the EU MDR regulation and Post Market Surveillance requirements
Strong communication and presentation skills
Competent in Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent)
Ability to prioritize, focus, collaborate, and work effectively in a fast paced and dynamic cross functional environment
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 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
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
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