Quality Engineer II

Company Description

Life Science Outsourcing, Inc. (“LSO”) (www.lso-inc.com) is a contract manufacturing organization focused on assembly, packaging, sterilization, and packaging with over 25 years of experience. The Company serves orthopedic, cardiovascular, diagnostic, dental and a variety of other medical specialties. Our unique model is focused on in-house end-to-end portfolio processes and service offerings with deep regulatory knowledge. This provides the agility and flexibility that customers need to accelerate their go-to-market launches while standardizing their supply chain and mitigating risk. Clients rely on LSO to perform all activities required to introduce their products to market, from procurement to final packaging and shipping.

LSO’s is headquartered in Brea, CA (North Orange County). In January 2023, the Company added its east coast facility in Somersworth, New Hampshire (formerly J-Pac Medical).

We are currently seeking a self-motivated Quality Engineer II with positive, engagement and collaborative energy to join our team and support the continued growth of the New Hampshire Facility. The Quality Engineer II will be responsible for overseeing 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.

Essential Duties and Responsibilities include the following.   NOTE: Other duties may be assigned.

• Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Develop, document, and implement QA procedures

• Interpret and assess conformity to regulatory standards. Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Provide analytical investigations and develop root cause for non-conformances

• 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 to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Write protocols, analyze data, and generate summary reports for verifications and validations
• Administrator for the e-QMS system and document control activities.
• Interface with vendors and customers as required

• Participate in MRBs, pFMEA, risk management reviews, validations, CAPAs, NCMRs, etc. Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.
• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

• Conduct supplier evaluations, qualifications, and quality audits
• Supplier Quality Tracking (assists in Supplier Quality Audits and managing Supplier Corrective Actions as required)
• Reviewing all lab results and approve product release. Backup for inspection and test (incoming, in-process & final)
• Working in a fast-paced team environment
• Assisting/Participating in Customer Audits (as needed)

Education and Experience

• BS or MS in Engineering, or scientific disciple with 2-4 years of experience in the manufacture of medical devices/disposables (Class I & II) for the medical device market
• 3 years Medical Device industry with microbiology and sterilization 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 is a plus
• Clean room manufacturing experience preferred
• Team player with strong communication, interpersonal, and presentation skills
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, drawings with GD&T interpretation, and procedure manuals
• Strong computer, math, writing, and problem-solving skills
• Solid understanding of statistics involving sample size selection, Cpk analysis, Gage R&R and tolerance analysis. Knowledge of DOE is a plus. Ability to use Minitab at intermediate level.
• Good 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 and six sigma manufacturing principles is a plus, Green Belt preferred.

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)