Manufacturing Operations Manager

6 days ago

Penang, Malaysia Link Compliance Full time

At Link Compliance, we are seeking a skilled Manufacturing Operations Manager to oversee the development and implementation of manufacturing processes for our award-winning AED and cardiac arrest response system.

Key Responsibilities:
  • Project Management:
  • Develop and coordinate tactical plans with CM technical staff, and regularly report status
  • Oversee day-to-day activities at the CM with a focus on driving on-time completion of activities per agreed to schedule and commit dates.
  • Overcome schedule challenges and delays to keep projects on-track.
  • Manufacturing Engineering:
  • Interface with contract manufacturer and US based engineering teams, representing the company interests and bridging time differences.
  • Exercise engineering judgement of part, process, and product issues throughout the CM facility to minimize production down time and bridge the gap until US engineering resources are available.
  • Read/understand, and support execution of test protocols, perform/oversee testing, and review or author reports to support test method validation (TMV), process validation (IQ, OQ, PQ), intended use validation (IUV), flowcharts, PFMEA, DOE, Gage R&R in accordance with FDA and ISO quality system regulations.
  • Analyze and recommend improvements to existing processes using Lean Manufacturing principles.
  • Read and interpret standard engineering drawings, and understand GD&T and tolerance stack up analysis
  • Observe contract manufacturing to ensure adherence to common good manufacturing practices (CGMPs) and applicable FDA and ISO quality system regulations.
  • Comply with FDA 21 CFR Part 820 and ISO 13485:2016 quality system regulations used in the Medical Device Industry.
  • Interface with Quality group to resolve Manufacturing related issues, using different quality tools such as 5whys, cause and effect diagram, etc. and problem-solving methodologies such as Six Sigma.
  • Contribute to functions outside areas of direct responsibility including but not limited to Supplier Quality and support fulfilling requirements such as supplier surveys, supplier assessments, audits, continuous improvement, etc.
  • Coordinate with appropriate suppliers and other external resources needed in developing and implementing process improvement plans.
  • Initiate/participate in weekly/monthly quality review and metric meetings and drive KPIs to meet target goals.
  • Assists with corrective/preventive action planning and implementation.
  • Enforce strict change control requirements with the CM as defined per the CM Quality Agreement.
Requirements:
  • Bachelor's degree or higher in Mechanical/Manufacturing Engineering or related discipline.
  • 2+ years of project management/manufacturing engineering experience in medical device industry supporting a FDA Class III medical device.
  • Experience working with/in contract manufacturing environment.
  • 'Hands-on' mechanical aptitude, engineering acumen and analytical skills
  • Ability to read and understand engineering drawings.
  • Process implementation and process validation experience.
  • Experience with software based mechanical medical devices and products.
  • Solid organizational planning, communication skills, articulate, team player, dependable, able to work in a fast-paced environment with accuracy/efficiency.

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