The Quality Engineering & Manufacturing Manager will support continuance improvement of product, process and QMS and provide guidance and support to all duties associated with the auditing and documentation of compliance related items against GMP and ISO standards and its subcontractors. The Quality Engineering & Manufacturing Manager will also lead a team executing the QMS related transactions in relevant GMP systems (MasterControl, SAP, Share Point) and other relevant quality functions as applicable including external and internal audit support.
Essential Duties and Responsibilities:
Exhibit a strong quality first mentality and ensure that product, process and QMS are held to the highest standard.
Provide guidance on Ops, technical and engineering processes/documentation to ensure compliance to procedures, relevant regulations and standards.
Lead Sr. Quality Eng., team leaders, Quality Engineers and Quality personnel in the day-to-day activities- supervise performance and tasks handling, set priorities, training, and objectives according to the organizational goals.
Lead Sr. Quality Engineers and QEs who review and approve technical/ Engineering documentation (DMR, IQ, OQ, PQ, product specifications, process validation and qualification activities, FMEA risk documents, test methods, protocols, reports, OOSs, design transfer, etc.) in relation to medical devices.
Lead the Quality involvement in design and maintenance of product and production process and hazard analysis in accordance with policies and procedures.
Provide Quality oversight and guidance to design transfer and process qualification and validation activities to other Sr. QEs.
Provide quality oversight, approval and guidance for qualification documentation and reports
Provide direction and guidance with problem solving techniques for technical and process reviews in cases of escalations.
Lead the sites device sterilization methods establishment, validation, maintenance and routine controls as the site sterilization SME by verifying that the sterilization methods validation is done according to the applicable standards and regulations. Verify the sterilization methods and risk-based approach are routinely maintained. Address sterilization issues and provide solutions to sterilization challenges. Be a part of the Global Sterilization Council and provide support to other CM and Medical device sites with Ster
Requirements: B.Sc. in Engineering or Science required
Minimum 10 years working in Medical Device / Pharma industry- in Quality roles
Minimum 8 years working in the areas of design controls/process validation
Experience with customer interface and meeting customer expectations
Experience with Medical Device Design & Development, Verification / Validation Activities, Risk Management, Product Transfer, DHF Activities
Must have an in-depth knowledge of product verification and process validations in a Medical Device environment
Strong working knowledge of quality systems such as ISO 13485, 21 CFR 820, ISO 14971, MDSAP
Knowledge in applicable sterilization standards and methods, such as ISO 11137 and ISO 11135
Excellent written and oral communication skills
Excellent critical reading and writing skills
Must have effective problem solving and interpersonal skills
Ability to work independently, multi-task and thrive in fast-paced environment
Problem solving including root cause failure analysis methods
Proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power Point
Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
Able to comply with the companys safety policy at all times
This position is open to all candidates.