quality engineer - Somersworth, United States - Life Science Outsourcing

Life Science Outsourcing Somersworth, United States

3 weeks ago

Description

Company ) is in North Orange County in the city of Brea, California.

Life Science Outsourcing, Inc (LSO) is a contract manufacturer of medical devices with in-built capabilities to offer clients full-service solutions through our six divisions.

Clients rely on LSO to perform all activities required to introduce their products to market, from sourcing to drop shipping.

In January of 2023 LSO acquired J-Pac Medical (www.j-), a Medical Device Contract Manufacturer based out of New Hampshire to expand LSOs geographic reach in the medical device arena.

Due to the recent acquisition and with over 25 years of growth, we are currently seeking a self-motivated Quality Engineer with a good positive energy to join our team at the New Hampshire Facility in Somersworth.

The Quality Engineer's role is to ensure the continual improvement of medical devices as well as the design and manufacturing of new devices.

Your duties are to develop prototypes, assess the quality of manufacturing standards, and develop guidelines for technological improvement.
We encourage you to submit a resume with salary requirements.
Job DescriptionEssential Duties and Responsibilitiesinclude the following.

NOTE:
Other duties may be assigned.

Develop, document, and implement QA proceduresInterpret and assess conformity to regulatory standardsProvide analytical investigations and develop root cause for non-conformancesDesign and specify gauging and test equipment for quality assuranceWrite protocols, analyze data, and generate summary reports for verifications and validationsLead and participate in design control projects for new and changing medical devicesInterface with vendors and customers as requiredParticipate in design reviews, pFMEA, risk management reviews, validations, CAPAs, NCMRs, etc.

Conduct supplier evaluations, qualifications, and quality auditsReviewing all lab results and approve product release.
Working in a team environment with Quality Department and J

Pac Medical personnel.

Supplier Quality Tracking (assist in Supplier Quality Audits as required)backup for inspection and test (incoming, in-process & final)Assisting/Participating in Customer Audits (as needed)QualificationsEducation and ExperienceBS or MS in Engineering, or scientific disciple with 5-7 years of experience in the manufacture of medical devices/disposables (Class II) for the medical device market3 years Medical Device industry experience preferredCertified Quality Engineer or Quality Auditor (ASQ) preferredExperience with design control, process validation, failure investigations, root cause analysis, and the application of statistics to the practice of quality assuranceExperience participating in FMEAs or other risk assessment activitiesExperience with supporting FDA and certified body auditsClean room experienceTeam player with strong communication, interpersonal, and presentation skillsAbility to read and interpret documents such as safety rules, operating and maintenance instructions, drawings, and procedure manualsStrong computer, math, writing, and problem-solving skillsExpert understanding of GMP, quality systems, ISO 13485, and FDA QSR for medical devices; knowledge of ISO 14971 and device-related compliance standardsKnowledge of lean manufacturing principlesSkills and AbilitiesPossess high level of energy.

Strong verbal and written communications skills.
Organized with strong record keeping and follow-up skills.
Strong regard for exceptional customer service (internal/external), ability to address and resolve customer problems.

Attention to detail in a fast-paced environmentAbility to work independently and take initiativeGood interpersonal, communication (both verbal and written)Additional InformationAll your information will be kept confidential according to EEO guidelines.

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