Sr. Quality Engineer # JN -042021-62675
Posted on: April 14, 2021
Industry: Database Administrator / Engineers
Job Number: JN -042021-62675
Title: Sr. Quality Engineer
Location: Tigard, OR
Duration: 6 Months Contract
- A Senior Quality Assurance Engineer assures products, processes, and quality records conform to quality standards and establishes compliance with the quality system.
- Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient safety and meeting business needs.
- Lead on-time completion of Quality Assurance (QA) engineering deliverables.
- Accountable for leadership, decision making, and oversight of the quality systems, including CAPA (Corrective and Preventive Action) systems.
- Works with and influences key stakeholders to develop and maintain QA procedures, forms, and systems.
- Develop and lead training for QA systems. Influence and guide other team members with product review and analysis for QA activities.
- Maintain databases and record storage for QA systems.
- Process QA requests, ensuring owners are assigned, and timely responses are provided in alignment with quality goals.
- Lead meetings and communications for QA system information, concerns, and updates.
- Lead and mentor others with QA data analysis, trending, and reporting.
- High proficiency with reporting and publishing weekly, monthly, and quarterly metrics.
- Track and proactively identify concerns manufacturing related complaints in alignment with SJM goals.
- Plan ahead for various data storage needs and communicate plans clearly to prevent potential system issues. Seeks out information independently and able mentor/lead other members of the organization on QA practices. Lead Global CAPA team with training, CAPA oversight, and CAPA deliverables.
- Proficient as lead representative for presenting QA System to internal and external auditors.
- Investigate and resolve system nonconformances and concerns (defined during internal and external audits).
- As appropriate, leads in the completion of risk assessment, as related to QA systems.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Performs other related duties and responsibilities, on occasion, as assigned.
- Operates a motor vehicle for trips to various Company sites and outside vendor, field, and customer locations; and to commute to various airports for airline.
- Activities require a significant amount of sitting in front of a computer monitor, some standing and walking. Significant use of hands and arms, plus finger dexterity to reach, point, write, type, operate a computer and other office equipment.
- Performs tasks that regularly require good correctable vision and hand/eye coordination.
- Activities also require significant use of voice and hearing for discussions with other employees.
- Bachelor level degree in Engineering, Technical Field, or equivalent (advanced degree preferred) 5+ years technical experience
- Previous Quality assurance/engineering experience and demonstrated use of Quality tools/methodologies
- Detailed knowledge of FDA, GMP, and ISO 13485
- Solid communication and interpersonal skills
- Demonstrated and impactful project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
- Advanced computer skills, including statistical/data analysis and report writing skills
- Prior medical device experience preferred ASQ CQT, CQE, CQA certification preferred Six Sigma root cause analysis/problem solving training and experience preferred.
- Experience working in a broader enterprise/cross-division business unit model preferred.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Ability to leverage and/or engage others to accomplish projects.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
- Ability to travel approximately 10%, including internationally.
- Ability to maintain regular and predictable attendance.
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