Staff Quality Engineer Product Development

Job Responsibilities:

• Technical leadership skills including an understanding of medical device operations (e.g. medical device manufacturing process development quality assurance) and chemical and pharmaceutical operations (e.g. drug product manufacturing analytical testing process development and quality assurance)

• Ability to create support review and investigate analytical test methods used to support pharmaceutical combination devices.

• The ability to create support review chemistry manufacturing and controls device submissions

• Participates as team leader or as an active member of the team to meet company objectives and ensure department responsibilities are completed

• Leads development of risk assessments and test method activities (e.g. development and validation for physical and analytical test methods)

• Leads component qualifications design validation design verification drug stability and process validation

• Leads product investigations

• Ability to make and present risked based decisions

• Assess product changes against product design

• Supports translation of design inputs into manufacturing control plans

• Develop and implement procedures to comply with corporate and industry standards.

• Coordinates and/or directs all aspects of product development activity related to a product line

• Leads development of risk assessments and test methods

• Quality engineering representation on Product Development and Design Review teams

• Prepare and present project updates and technical discussions

• Participate in project planning budgeting scheduling and tracking

• Support internal and external supplier audits

• Provide support to the regulatory department in writing technical submissions

• Complies with company procedures and policies government regulations

• Actively participates in training and providing input to training of employees on division procedures and policies

• Ability to travel for business project and issues approximately up to 25% of time.

• Other duties and projects as assigned

Required Education and Experience:

• BS in Engineering Biological Science or a related engineering field (Masters or Ph.D preferred). Fields of study include Chemical Engineering Bioengineering Pharmacy or Biochemistry

• Minimum of eight years of experience in engineering or Quality engineering experience within the medical device pharmaceutical or equivalent industry

• Extensive proven understanding of design controls in development stage

• Pharmaceutical or combination product experience

Required Qualifications:

• Apply Quality Engineering tools (Sampling Plans Root Cause Analysis Statistics etc.)

• Ability to lead creation of risk management files

• Ability to develop solutions with business impact

• Advanced statistical and risk assessment techniques

• Working knowledge of test method (development and validation) equipment qualifications process and design validation risk assessment techniques and component qualification methodologies

• Ability to make and present risk-based decisions

• Strong interpersonal skills

• Ability to analyze and optimize manufacturing and quality systems

• Product design & prototyping

• Ability to create and provide training

• Problem solving ability

• Ability to create review and coordinate test protocols and reports

• Ability to generate engineering proposals

• Oral and written presentation skills

• Ability to lead cross functional teams

• Understanding of regulatory requirements including ISO 13485 ISOCFR 210/211/820 ICH Guidelines