LIGHTHOUSE is the leading global provider of laser-based, non-destructive headspace analysis platforms. Our range of benchtop and in-line platforms with patented laser sensor technology is used to analyze pharmaceutical products and packages and monitor sterile product processes across the product life cycle. In addition to supplying headspace platforms, LIGHTHOUSE offers measurement services and leases equipment from laboratory facilities in Charlottesville, VA, and Amsterdam. Our highly-trained team of Application Scientists supports customers with outsourced testing services, scientific studies, and lease equipment projects.
Lighthouse Instruments has an immediate career opportunity for a Quality Engineer.
The Quality Engineer is primarily responsible for establishing and maintaining an effective and efficient quality system for all business units within Lighthouse Instruments. The position will work with senior management and industry subject matter experts to implement and maintain a quality system compliant with ISO 9001 and adding elements of additional ISO standards (17025 and 17034) as business needs dictate.
- Actively drive quality initiatives to achieve company objectives and ensure compliance with customer needs and expectations.
- Analyze data, process capabilities, customer concerns and expectations, and any other leading or lagging indicators that may be used to improve product and process knowledge.
- Leads and performs internal audits to ensure compliance with established procedures and identify quality system weaknesses that need improvement.
- Manage the CAPA process, including the review and approval to open new CAPAs and approving CAPA plans, timelines, and verification of effectiveness plans to ensure timely completion within the established goal.
- Lead investigation and root cause analysis of internal deviations and non-conformance
- Provides expertise and guidance to site personnel using root cause analysis tools for investigations/continuous improvements.
- Assists with process, documents, procedures, and forms changes as
- Oversee equipment validation and calibration
- Perform internal quality systems audits in accordance with ISO standards, including recommending ways to resolve any issues identified by the audits.
- Participates in all customer audits (onsite and paper audits).
- Performs other duties as required
Experience and Qualifications
- Required: Bachelor’s degree in Life or Physical Sciences or Engineering
- Minimum of 7 years of experience in instrumentation manufacturing or lab activities (at least three years of which must be in a Quality function).
- Strong working knowledge of ISO 9001:2015
- General knowledge of ISO 17025, ISO 17034, and cGMPs
- Proficiency with Microsoft Office and Google Suites.
- Highly motivated and self-driven.
- Responsive and customer service oriented both internally and externally.
- Effective problem analysis and resolution skills.
- Possesses above-average attention to detail, demonstrating accuracy and thoroughness.
- Active listening and clear communication skills: verbal, written, and presentation skills (e.g., grammar, writing, and editing) to interact professionally with individuals, internally with co-workers, and externally with vendors and customers required.
- Above average ability to be flexible, organize, manage time, and set/shift priorities while meeting deadlines required.
- A team player who can cultivate a team spirit within the department and maintain positive interdepartmental collaboration.
- Above-average interpersonal and relationship skills are essential, with the ability to handle sensitive, stressful, and confidential situations with poise, tact, and diplomacy.
- Ability to interpret, adapt, and apply Organization guidelines and procedures within the position and the department.
If you are an aspiring quality leader, we are looking for a talented early-career quality professional ready for a leadership role. This position will work with senior management and external experts on implementing ISO9001 and ISO17034 quality management systems at Lighthouse Instruments.
Lighthouse Instruments LLC is an equal-opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the U.S. includes race, color, religion, natural origin, sex, gender identity, sexual orientation, physical and mental disabilities, pregnancy, genetic information, military or veteran status, or any other protected classification. Equal employment opportunity includes but is not limited to hiring, training, promotion, demotion, transfer, leave of absence, and termination.
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- Fitness & Health Programs
- PTO & Wellness Programs
- Parental Leave
- Tuition Assistance
- Professional Development
- Discretionary Bonus Program
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