quality engineer - Somersworth, United States - Life Science Outsourcing

Description

Company Description

) 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 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.