Senior Quality Risk Management Engineer

The Senior Quality Engineer is responsible for carrying out Manufacturing Quality Assurance functions within the plant including resolution of deviations, performance of product impact analysis and corrective and preventive action for events, leading and participating in investigations, approval of standard operating procedures, oversight of the plant calibration program, quality improvement programs, and assurance of cGMP and Abbott policy compliance for the manufacturing plant.
Supports the Quality Engineering group by auditing of commissioning and validation documentation completed by others, authoring and execution of newly identified qualification/validation protocols, review and approval of critical planned maintenance routines, and other quality assurance tasks assigned by the MQA Section Manager and/or the Plant QA Manager.
Responsibilities
Serve as the site liaison between the Quality Risk Management Center of Excellence (QRM COE) and local stakeholders to support deployment of global QRM processes and communication of site feedback.
Provide QRM SME oversight and guidance for risk management activities, such as FMEAs and other risk assessments specified in local and/or global procedures, by supporting cross-functional teams with methodology, procedural expectations, documentation quality, and risk-based rationale
Provide QRM training and guidance as required, facilitate assignment of appropriate QRM training curricula to site personnel based on their risk-related responsibilities, and promote QRM best practices.
Support Management Review activities by compiling and presenting required QRM metrics, site plans for upcoming FMEAs or other relevant risk assessments, significant residual risks, upcoming and past due mitigation actions.
Monitor the site Quality Risk Management program to support adherence to global QRM procedures, risk outputs, and mitigation action status.
Participate in global and local QRM documentation changes and change control activities by assessing site impact and providing QRM input as applicable.
Participate in the Validation Review Board discussions as the QRM SME, providing risk-based input to support validation, commissioning, qualification, and change-related decisions.
Support the ensure that all quality goals are met, and all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility.
Own and maintain applicable site-level Quality Risk Management documents and provide QRM expertise for the development, review, and facilitation of risk assessments used to support risk-based decisions, quality event investigations, and other site or product-specific risk evaluations.
Bachelor's degree, preferably in Biology, Chemistry or Engineering
6+ years of overall experience in Manufacturing, Quality or Engineering
Good verbal and written communication skills.
Good problem solving and analytical skills
Good interpersonal relations / communications skills
Good negotiation skills
Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing.

Skills
Risk Management, Negotiation, Auditing, Documentation

Employment type
Full-time

Work arrangement
No