Valeant Pharmaceuticals

Senior Engineer Quality

US-WA-Bothell
Job ID
9739
Category
Quality
Pos. Type
Full Time

Overview

Valeant Pharmaceuticals International, Inc. is a diverse and decentralized pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what we hope it will become.

 

The Sr Quality Engineer is a key member of Solta’s Quality staff. The Sr Quality Engineer is expected to proactively provide innovative Quality solutions and leadership based on their extensive knowledge and experience in medical device Quality Engineering. This individual is proficient in standards, safety agency compliance, risk management, product development, and verification activities, and all Quality processes specific to our industry.

 

Work Environment:
Most work will be performed in an office and light-manufacturing environment. The noise level in the work environment is usually low to moderate.

 

Safety:
Solta Medical is committed to the health and safety of our employees. We expect that all employees will perform their responsibilities while maintaining a safe, cooperative, and productive work environment, thus ensuring the health and safety of themselves and others. 

Responsibilities

  • Support daily production activities and review change orders for adequacy
  • Provide input from concept to production on all quality related issues
  • Develop Quality Engineering deliverables in compliance with applicable standards
  • Maintain current knowledge of federal, state, and international regulations regarding safety agency, GMP, ISO, MDD, and quality assurance 
  • Participate in the project risk management activities including establishing risk documents such as risk management plans/reports and risk analysis 
  • Ensure all documentation, reports, tests and results meet the requirements of Regulatory Filings and Technical files for CE filings 
  • Identify and communicate product safety requirements to design team 
  • Work with manufacturing engineering to plan, execute, and document process validations
  • Support daily production activities and review change orders for adequacy
  • Participate in supplier assessment, corrective action, and audits
  • Act as the quality representative for inspection and Material Review Board (MRB) activities
  • Participate in the SOP writing and ensure that all Solta Medical employees follow written SOPs and process specifications
  • Participate in product complaint and corrective action system. Perform and support complaint and CAPA activities.
  • Plan, schedule, and complete projects in an aggressive, sense of urgency manner consistent with corporate objectives


Other Responsibilities and Duties:

  • Participate in Regulatory activities as required
  • Participate in audits including internal, FDA and Notified Body

Qualifications

  • This position requires a minimum of an undergraduate degree in Engineering (preferably in Electrical or Mechanical engineering) or equivalent experience.
  • Medical device industry background preferred.
  • Extensive knowledge and experience in device development and manufacturing, from concept to release and distribution.
  • Extensive knowledge of the requirements for international quality systems, including ISO 13485, MDD, Vigilance Systems, Notified Bodies, CE marking and IEC 60601. 
  • Strong collaboration and development skills.
  • Proactive, team player, enthusiastic, with high work ethics
  • PC experience with Microsoft Office applications (Outlook, Word, Excel, Visio, Microsoft Project, Power Point)
  • High level of attention to details, capable of efficient use of time and project management skills essential

 

Language and Verbal Skills

  • Ability to read, analyze, and interpret engineering drawings and specifications, general business periodicals, professional journals, technical procedures, or governmental regulations.
  • Ability to write reports, specifications, business correspondence, and procedure manuals in English.
  • Ability to effectively present information and respond to questions from groups of managers, clients, and customers.
  • Ability to clearly and concisely convey project accomplishments, obstacles, issues, and project status.

Math Skills

  • Ability to work with mathematical concepts such as probability and statistical inference, process capabilities and fundamentals of plane and solid geometry and trigonometry.
  • Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
  • Ability to use MS Excel to perform calculations and interpret project results/data.

 

Analytical and Reading Skills

  • Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
  • Ability to read technical and clinical literature and documents and extract important concepts.

 

Physical Requirements

  • May be required to perform lifting tasks of up to 30 pounds for short durations. Duties of this job may involve standing and/or walking for extended periods of time. Duties also involve daily keyboard data entry. Specific vision abilities required by this job include close vision.

Be Aware of Recruiting Fraud

Valeant is an EEO/AA employer M/F/D/V.

 

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

 

To learn more please read Valeant’s Job Offer Fraud Statement.

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