Planet Pharma · 1 day ago
Quality Assurance Engineer
Woburn, MA
Contract
Onsite
Mid Level
3+ years expPlanet Pharma is seeking a Quality Assurance Engineer to provide Quality Engineering support in the execution of manufacturing and risk management deliverables. The role involves ensuring compliance with global medical device regulations, conducting risk assessments, and supporting complaint handling and design controls.
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 internal Quality System requirements
Conduct risk assessments and implement risk management strategies to address potential quality issues throughout the product lifecycle
Support root cause analysis and corrective action processes for non-conformities, including the development and implementation of preventative measures
Generate and ensure compliant completion of Quality deliverables, including change requests, risk management deliverables, test methods, process validation, packaging and labeling documentation, SOPs, and manufacturing work instructions. Ensure all documentation is accurate and up to date
Assist with internal and external audits to assess the effectiveness of the quality management system and ensure compliance with regulatory and company standards
Provide key quality trending information and data for use in periodic reviews
Investigate customer complaints and analyze feedback to identify trends and drive improvements to product quality and customer satisfaction
Evaluate and monitor suppliers for quality performance. Collaborate with suppliers to address and resolve quality issues
Be flexible and work within a small team without strictly defined roles to assure complete functional coverage
Qualification
Required
BS in STEM (Science, Technology, Engineering, Mathematics)
3–5 years of Quality Engineering experience in the medical devices or pharmaceutical industry with demonstrated competency of 21 CFR 820, EU MDR, EN ISO 13485, and EN ISO 14971
Strong communication and presentation skills; energetic, proactive, and flexible with high integrity and ethics in all dealings
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