Quality Engineer

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.

• Manage site validation activities encompassing equipment qualification, and software and process validations. Maintain Validation Master Plans. Provide support during product and process validations by guiding the team through IQ, OQ, and PQ stages of the validation process. Review, approve, author, and execute validation protocols and reports.
• Manage site change order process to assess and appropriately document risk including impact to internal and customer-related processes. Coordinate with functional teams across multiple sites to ensure timely completion of change activities.
•  Work with Manufacturing Operations, QC, and Technical Support to evaluate production processes and monitor product quality performance. Collaboratively solve manufacturing and quality issues.
• Investigate quality issues and trends from customer complaints, NCRs, CAPAs, etc. to identify actions required.
• Participate in and lead teams during the investigation of root cause, quality problems, and complaints using statistical techniques (DOE, ANOVA, Regression, Analysis, etc.). Implement appropriate and efficient corrective actions to avoid problems and/or prevent recurrence.
• Review and approve Document Change Requests (DCRs) related to materials, production processes, test methods, and quality plans as required.
• Oversee risk management documentation with deliverables including risk plans, risk assessments (design and process FMEAs), and risk reports. Review risk control actions for completeness, feasibility and adequacy. Track mitigation efforts to reduce medium and high risks to acceptable levels.
• Identify improvements to reduce scrap, rework, complaints, and other sources of Cost of Poor Quality (COPQ) in line with quality and cost reduction initiatives.
• Initiate SOP changes to streamline, standardize, and improve quality system processes.
• Support large-scale projects such as electronic systems implementation and integration.
• Support ongoing product release activities such as review of raw material receipts, batch records, QC results, and environmental monitoring records. Assess excursions with appropriate deviations and/or risk evaluations.
• Work with Facilities to evaluate equipment performance requirements and management of calibration, preventive maintenance, and unscheduled repair activities. Review controlled space monitoring reports and evaluate Out of Tolerance (OOT) and repair events for impact to product quality. 
• Support product stability studies through careful review of challenge conditions and requirements.
• Perform internal and supplier audits, issue audit reports, and follow up to close out actions which address the findings.
• Provide training and support for quality concepts and tools.

Education and/or Experience

• Bachelor’s Degree in a scientific discipline with experience in quality engineering
• 5 + years’ experience working in a cGMP or ISO 13485 environment

Knowledge, Experience and Technical Skills

• Ability to interpret FDA QSR regulations as well as ISO 13485 and ISO 14971
• Comprehensive validation experience including ability to guide prospective, concurrent, and retrospective studies
• Knowledge of statistical methodologies, quality control and manufacturing operations
• Ability to strategically evaluate and implement practical, timely resolution of non-conformances, deviations, customer complaints, and CAPAs
• Intermediate to advanced computer skills with word-processing systems, spreadsheets, databases, ERP systems, and electronic quality management system software
• Strong interpersonal, organizational, verbal and written communication skills
• Demonstrates curiosity, adaptability and commitment; works best in a team environment and actively seeks to foster relationships
• Focused on problem solving including problem definition, risk evaluation, and risk-based resolution
•  Ability to ask probing questions to understand unstated expectations and underlying issues, understand competing priorities, and facilitate discussions to gain consensus through the problem solving process
•  Oriented for continuous improvement with desire to always balance the level of control and flexibility in systems based on risk
• Strong analytical and examination capabilities for complex projects; ability to develop process maps, organize data, evaluate options, document plans, and communicate progress.
• Strong attention to detail
• Performance driven with ability to work positively and collaboratively with cross-functional team
•  Ability to manage multiple tasks and meet timelines with minimal supervision

LGC recognizes benefits are key resources as you navigate your well-being journey. We’re pleased to offer comprehensive programs that are focused on supporting our employees and families’ well-being. Many of our benefit programs are effective the 1st of the month following hire date.

· Comprehensive medical, dental, and vision benefits for employees and dependents

· FSA/HSA Pre-tax savings plans for health care, childcare, and elder care

· 401(k) retirement plan with matching employer contribution

· 100% paid parental leave, up to 8 weeks

· 100% paid Caregiver leave, up to 3 weeks

· Paid Holidays, which include floating days and a holiday shutdown in December

· Company paid Basic Life / Accidental Death

· Company paid Short & Long-Term Disability

· Company paid Employee Assistance Program

· Health Savings Accounts

· Flexible Spending Accounts (Healthcare and Dependent Care)

· Identity Theft & Protection

· Legal Services

· Pet Insurance

· Voluntary Worksite Benefits

· Tuition Reimbursement

· Employee Referral Program

The annual base pay range for this FLSA exempt role is: Minimum: $88,000 to Maximum: $132,000

The pay range represents the low and high end of the current salary range for the Maryland-based position. This range is provided as a general guideline and is not a guarantee of compensation or salary. A new hire meeting qualifications is typically evaluated towards the minimum through the middle of the salary range. Factors considered for salary include, but are not limited to, education, number of years of Quality Engineering experience, job-relevant knowledge, skills, abilities, internal equity, and alignment with market data.

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 maternity, religion, or belief. Short listing,

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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