About the job
The Sr. Quality Engineer will lead in the implementation of quality assurances practices, process controls, change control and Corrective and Preventive Action activities. This position is embedded in the Operations Work Stream. The Sr. Quality Engineer will partner with Operations and is the primary point of contact for all quality decisions affecting daily activities.The Sr. Quality Engineer will approve investigations, deviations, change controls, validation protocols, validation reports, Operations SOP’s, and in-process controls. In addition, they will evaluate and recommend process changes to improve the Value Stream performance and regulatory compliance.
The individual selected for this role will act as an effective leader in promoting quality disciplines, decisions and practices and will apply sound, systematic, problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues.
- Key Responsibilities:
- Provide Quality review and approval of all investigations, deviations, change controls, validation protocols, validation reports, SOP’s, and in-process controls in support of the assigned Value Stream.
- Enable collaborative relationships between Operations and Quality with the overall focus of improving customer satisfaction.
- Troubleshoot process issues. Lead inter-department teams in the resolution of process issues and quality problems.
- Work as a member of new product introduction teams to provide quality input and capability analysis.
- Work closely with Operations, R & D, Purchasing and Engineering to improve quality while reducing material scrap and costs.
- Champion continuous improvement and the transition to a Lean Manufacturing Environment.
- Drive quality management focus on productivity improvements throughout the business unit.
- Work effectively as a member of cross-functional teams.
- Partner with Operations leadership to establish controls and inspection points to facilitate detection, correction, and prevention of nonconforming materials, parts, assemblies, and products.
- Drive Customer complaints to resolution; Serve as Quality Representative for all quality-related corrective/preventive actions within the Value Stream.
- Assure that quality standards comply with division and departmental policies, national and international codes, and applicable safety requirements.
- Leads PPI activities at the site including the facilitation of Kaizen events. Supports Operations and Quality team members on process improvement activities.
- Analyze trends and collaborates with manufacturing to investigate trends, conduct root cause analysis and lead corrective actions for processes and products.
- Manage Validation personnel reporting to the position to effectively develop, recruit, train, evaluate, motivate, delegate and monitor their work as it relates to the assigned value stream and Quality goals.
- Bachelor’s degree required in engineering or related field with a minimum of 6 years of quality assurance experience in a medical device or pharmaceutical manufacturing environment.
- Strong background in process control and statistical techniques. ASQ certification a plus.
- Medical device, GMP, EU Regulation or ISO 13485 background.
- Demonstrated working knowledge of compliance, quality and scientific principles.
- Strong oral and written communication skills.
- Must be a self-starter who can take general concepts and direction and produce desirable results.
- Ability to prioritize multiple tasks function effectively in a global, multi-site organization.
- Demonstrated ability to work effectively as a member of a cross-functional team.
- Strong working knowledge of quality related tools, such as structured problem solving, FMEA (Failure Mode and Effects Analysis), SPC (Statistical Process Control), DOE (Design of Experiments) and Six Sigma.
- Strong working knowledge of various computer software, such as Mini-tab.
- Experience with lean manufacturing practices. Green Belt or Black Belt certification a plus.
- Knowledge of qualification / validation (process, sterilization, software) requirements.
- Previous Supervision or Management experience.
- Perform independently without continual direction and exercise considerable latitude in determining technical objectives and solutions to complex problems.
- May be required to perform other related duties as required and/or assigned.
- Excellent oral and written communication skills.
- Strong leadership skills with the ability to challenge, influence, and build consensus.
- Ability to work both independently and as a team member.
- Strong business acumen.
Posted on Feb 11, 2024.
