QUALITY ENGINEER
Company: Life Science Outsourcing
Location: Somersworth
Posted on: May 29, 2023
Job Description:
Company Description
(www.lso-inc.com) 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-pacmedical.com), 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 Description
Essential Duties and Responsibilitiesinclude the following. NOTE:
Other duties may be assigned.
- Develop, document, and implement QA procedures
- Interpret and assess conformity to regulatory standards
- Provide analytical investigations and develop root cause for
non-conformances
- Design and specify gauging and test equipment for quality
assurance
- Write protocols, analyze data, and generate summary reports for
verifications and validations
- Lead and participate in design control projects for new and
changing medical devices
- Interface with vendors and customers as required
- Participate in design reviews, pFMEA, risk management reviews,
validations, CAPAs, NCMRs, etc.
- Conduct supplier evaluations, qualifications, and quality
audits
- Reviewing 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)
Qualifications
Education and Experience
- BS 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 market
- 3 years Medical Device industry experience preferred
- Certified Quality Engineer or Quality Auditor (ASQ)
preferred
- Experience with design control, process validation, failure
investigations, root cause analysis, and the application of
statistics to the practice of quality assurance
- Experience participating in FMEAs or other risk assessment
activities
- Experience with supporting FDA and certified body audits
- Clean room experience
- Team player with strong communication, interpersonal, and
presentation skills
- Ability to read and interpret documents such as safety rules,
operating and maintenance instructions, drawings, and procedure
manuals
- Strong computer, math, writing, and problem-solving skills
- Expert understanding of GMP, quality systems, ISO 13485, and
FDA QSR for medical devices; knowledge of ISO 14971 and
device-related compliance standards
- Knowledge of lean manufacturing principles Skills and Abilities
- Possess 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 environment
- Ability to work independently and take initiative
- Good interpersonal, communication (both verbal and written)
Additional Information
All your information will be kept confidential according to EEO
guidelines.
Keywords: Life Science Outsourcing, New England , QUALITY ENGINEER, Engineering , Somersworth, Northeast
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