Quality Engineer
Quality Engineer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
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:
- Bachelors 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 qualityfocused 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 nonconformances 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 problemsolving 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 wellbeing 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: $88000 USD
Maximum: $132000 USD
This range represents the low and high end of the anticipated salary range for the Marylandbased 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 .
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Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
