Quality Engineer

Company Description

LGC is a leading, global life science tools company, providing mission-critical components and solutions into high-growth application areas across the human healthcare and applied market segments. Our high-quality product portfolio is comprised of mission-critical tools for genomic analysis and for quality assurance applications, which are typically embedded and recurring within our customers’ products and workflows and are valued for their performance, quality and range.

Our tools play a key role in customer workflows from discovery applications through to commercial manufacture and enable its customers to: bring new diagnostics and therapies to market; progress research and development; optimize food production; and continuously monitor and enhance the quality of food, the environment and consumer products.

LGC’s 175 years of scientific heritage, combined with a track record of innovation and value-enhancing acquisitions, has enabled the company to build its product portfolio and expertise, and develop deep relationships with customers, industry partners and the global scientific community.  Join us and help us achieve our mission of Science for a Safer World! 

LGC Clinical Diagnostics Business Unit is comprised of our operating entities including LGC Clinical Diagnostics, Inc. (f/k/a Maine Standards Company & SeraCare Life Sciences), Technopath Clinical Diagnostics, and the Native Antigen Company. Our 400 employees operate FDA-registered and ISO 13485-accredited facilities in Maine (USA), Massachusetts (USA), Maryland (USA), Tipperary (Ireland), and an ISO 9001-accredited facility in Oxford, UK. LGC Clinical Diagnostics is owned by LGC Group, a UK-headquartered life sciences measurement and testing business with >$510m of annual revenue and >3,500 employees globally.

Job Description

• Lead site validation activities, ensuring flawless equipment qualification and process validations.
• Maintain Validation Master Plans and provide crucial support during IQ, OQ, and PQ stages, reviewing and implementing validation protocols and reports to uphold high standards.
• Coordinate site change orders, you will assess risks to minimize impacts on processes. Close collaboration with Manufacturing Operations, QC, and Technical Support is essential in evaluating production processes and addressing quality issues efficiently.
• investigate quality trends from complaints and NCRs, applying statistical techniques to identify root causes and implementing corrective actions.
• Review Document Change Requests, managing risk documentation and ensuring completeness of risk control actions.

Qualifications

Minimum qualifications:

• Bachelor’s Degree in a scientific discipline with experience in quality engineering. 
• Candidates should have a minimum of 5 years in a cGMP or ISO 13485 environment, demonstrating a consistent record in quality-focused industries.

Preferred qualifications:

• Proficient in interpreting FDA QSR regulations, ISO 13485, and ISO 14971, with extensive experience in validation and guiding various study types, including prospective, concurrent, and retrospective studies.
• Knowledgeable in statistical methods, quality control, and manufacturing operations, skilled in evaluating and resolving non-conformances, deviations, customer complaints, and CAPAs.
• Intermediate to advanced computer skills, including proficiency in word processing, spreadsheets, databases, ERP systems, and electronic quality management software.
• Strong interpersonal and organizational skills, both verbal and written, with a curious and adaptable approach, dedicated to teamwork and collaboration.
• Focused on problem-solving, possessing skills in risk evaluation and resolution, able to ask probing questions to identify root issues and facilitate discussions for consensus.
• Committed to continuous improvement, balancing control and flexibility based on risk, with strong analytical abilities for managing complex projects.
• Diligent and meticulous, capable of managing multiple tasks and meeting deadlines independently.

Additional Information

LGC is dedicated to supporting the well-being of our employees and their families with comprehensive benefits from the commencement. Our benefit programs include medical, dental, and vision coverage, FSA/HSA plans, 401(k) matching, parental and caregiver leave, paid holidays, life insurance, disability coverage, an employee assistance program, and more.

The typical pay range for this role is:

Minimum: $88,000 USD

Maximum: $132,000 USD

This range represents the low and high end of the anticipated salary range for the Maryland-based position. The actual base salary will depend on several factors such as: experience, skills, and location.

This position is eligible for a discretionary bonus program. Participation in the bonus program is not guaranteed, and bonuses are awarded at the discretion of the company based on individual and company performance results.

LGC strongly believes that every job applicant and employee should be valued for their individual talents regardless of age, disability, race, color, ethnic or national origin, sex, sexual orientation, gender reassignment, marital or civil partnership, pregnancy or parenthood, religion, or belief. Shortlisting, interviewing, and selection will always be carried out without regard to gender, sexual orientation, marital status, color, race, nationality, ethnic or national origins, religion or belief, age, or trade union membership. For more information about LGC, please visit our website www.lgcgroup.com.

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