Sr. Quality Engineer
Sterling Life Sciences - Baltimore, MD

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1) Investigate, plan and implement improvements in and additions to current products and manufacturing processes that directly affect safety, quality and productivity with the end result of producing a better quality product more efficiently
2) Investigate, identify and implement best-in-class quality engineering practices
3) Provide focused quality engineering support and assume responsibility for timely and effective coordination and execution of assigned development project activities
4) Establish effective corrective action plans.
5) Lead in implementation of quality assurance plans, process controls and CAPA systems designed to meet or exceed internal and external requirements
6) Act as an effective leader or team member in supporting quality disciplines, decisions and practices
7) Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues
8) Review and approve product and process qualification and validation and other change control related documentation
9) Develop product/process assurance plans, which include all required elements
10) Identify and implement effective process control systems to support the development, qualification and on-going manufacturing of products to meet or exceed internal and external requirements
11) Generate internal quality documentation such as quality plans, standard operating procedures and inspection procedures
12) Participate in product review boards
13) Identify non-conformance trends and develop technical investigation plans
14) Investigate and analyze customer/internal complaints
15) Perform analytical measurements and experiments to qualify or resolve product and process issues
16) Develop and implement strategic quality plans, master validation plans, validation protocols, inspection plans and quality/regulatory compliance operating procedures to meet FDA (Food and Drug Administration) and ISO (International Organization of Standardization) requirements
17) Track quality trends and initiate action items to resolve issues and manage assigned corrective actions
18) Monitor field quality and analyze field returns to determine root cause
19) Provide training and support for quality system processes and quality engineering practices
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1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the medical device industry is strongly preferred
4) Preference will be given to people who have recent experience in quality engineering