Key Responsibilities

• Ensures all direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.
• Co-ordinate the work activities within the various work teams and ensuring that adequate resources are available; to meet customer expectations.
• Maintains and enhances cross-functional /site team relationships.
• Is an effective people manager resulting in a motivated high-performance team and is fully motivated to achieve and demonstrate best practices in line with the department and Strategic Quality Planning (SQP) objectives.
• Provides direction and support to subordinates based on general policies and management guidance.
• Responsible for performing performance appraisals, for all reporting staff.
• Co-ordination of staff holidays and for ensuring sufficient cover is available to support manufacturing during shut down periods.
• Selects appropriate techniques for problem solving and makes solid and consistent Engineering and Quality Assurance recommendations.
• Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
• Identify Manufacturing process defects (scrap, nonconforming material, customer complaints) by dispositioning non-conforming material, assisting in identification of primary root causes and understanding corrective and preventative actions. May be responsible for working with process owner to bound product stops and document release criteria.
• Participates in Customer Complaints investigation for areas under their control or Laboratory Out Of Specification (OOS) investigation.
• Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
• Is viewed as a leader in the areas of QSR and ISO/MDD standards within ones own group, constantly promotion awareness of best industry practices making appropriate decisions on a daily basis using the Quality Engineering Manager/Site QA Director as the final arbitrator on critical quality decisions.
• Reviews and approves operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
• Works with EHS to identify significant environmental impacts of Boston Scientific operations and to establish goals and targets around significant environmental impacts.
• Deals with suppliers, other engineering disciplines within and outside of Site and customers should the need arise.
• Is familiar with the internal auditing process.

Requirements

• Bachelor's Degree or Master's Degree in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, Biomedical Engineering, or a related scientific discipline.
• Minimum 5 to 8 years of experience in an analytical laboratory within the medical device, pharmaceutical, biotechnology, or other regulated industry.
• At least 2 to 3 years of experience in a supervisory or people leadership role.
• Hands-on experience with analytical testing techniques, including HPLC, dissolution testing, FTIR, GC, and other relevant analytical methods.
• Experience managing laboratory resources, workload planning, and capacity optimization.
• Proven ability to prioritize multiple projects while ensuring quality, compliance, and on-time delivery.

Required Skills

• Strong expertise in analytical chemistry principles and laboratory best practices.
• Proficiency in chromatographic techniques (HPLC/UPLC) and spectroscopy methods.
• Ability to interpret complex analytical data and provide scientifically sound conclusions.
• Knowledge of analytical method development, validation, verification, and robustness studies.
• Proven ability to lead, coach, and develop a team of analytical scientists and laboratory personnel.
• Strong project management and organizational skills.
• Effective problem-solving and decision-making capabilities.
• Strong communication and cross-functional collaboration skills.
• Knowledge of quality systems, regulatory requirements, and laboratory compliance standards.