38 applicantsPosted by Agency
Planet Pharma ยท 2 days ago
Principal/Senior Quality Engineer
Billerica, MA
Full-time
Onsite
Senior Level
7+ years exp
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Responsibilities
Develops, modifies, applies, and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
Devises and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
Designs or specifies inspection and testing mechanisms and equipment, conducts quality assurance tests, and performs statistical analysis.
Assesses the cost of products or materials that do not meet required standards and specifications and determines the responsibility.
Ensures corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
May specialize in design, incoming material, production control, product evaluation, reliability, inventory control, or research and development related to product or process quality.
Qualification
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Required
Ability to use statistical techniques to analyze data
Design of experiment/Process Characterization
Experience working in a fast-paced Manufacturing environment
Validation Experience (IQ, OQ, TMV, PQ)
CAPA (Corrective Action / Preventive Action) Experience
Familiarity with Minitab Statistical Software
Preferred
A Bachelor in Mechanical or Electrical Engineering with ability to build custom fixtures. Ability to read drawings, BOMs, GD&T.
Experience in mechanical assembly and components
Ability to work with vendors on dimensions and order components
Ability to qualify equipment in medical device mfg. assembly line
Experience in working in a med device company in a cleanroom environment
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
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
