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Senior Quality Engineer more...
Location:Chelsea, MA
Company:Acorda Therapeutics Inc.
First posted:September 09, 2016 (last updated 30+ days ago)
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Senior Quality Engineer

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Location

Chelsea, MA, United States

Summary

Responsible for conducting audits of GMP suppliers for drug device combination products and generating audit reports. The Quality Engineer collaborates with Quality leadership on the development of appropriate quality metrics and assists in the management of corrective and preventative actions as outcomes from the audits. This individual builds relationships with suppliers to effectively communicate and assure compliance to internal and external specifications and quality standards.

 

Full Description

Summary:

The Senior Quality Engineer has the following responsibilities:

Supplier Auditing: Responsible for conducting audits of GMP suppliers for drug device combination products and generating audit reports. The Quality Engineer collaborates with Quality leadership on the development of appropriate quality metrics and assists in the management of corrective and preventative actions as outcomes from the audits. This individual builds relationships with suppliers to effectively communicate and assure compliance to internal and external specifications and quality standards.

Internal Auditing: Responsible for planning, implementing, and managing compliance of manufacturing and production processes with internal and external safety, quality and regulatory standards requirements for worldwide distribution.

Internal Metrics for Management Review: Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.

* Essential Duties and Responsibilities include the following. Other duties may be assigned.

  • Provides oversight of supplier quality activities and review of deviations to identify trends with suppliers.
  • Oversees, reviews, and approves Materials Management and Supply Chain activities.
  • Gathers and performs statistical analysis of quality metrics data to evaluate supplier performance.
  • Generates audits and periodic supplier performance reports.
  • Documents and assists in the management of corrective and preventative actions.
  • Provides support to of Laboratory and Quality Investigations.
  • Ensures compliance with all Acorda policies and procedures involving the development and commercial manufacturing of drug device combination products.
  • Participates in the selection and qualification of new material and contract suppliers.

Education and/or Experience:

  • Bachelors degree in Engineering or scientific related field required.
  • Masters degree in Engineering or scientific related field preferred.
  • Minimum five to seven years of experience in a cGMP manufacturing environment is required.
  • Experience working in a FDA regulated operation conducting audits, preferably in medical devices.
  • Experience working in cross-functional teams for both development and commercial manufacturing involving launching commercial products and technology transfers

Supervisory Responsibilities: None

Qualifications:

  • Attention to technical detail and a strong understanding of manufacturing and or development processes required.
  • Strong hands on understanding of mechanical and electrical processes required.

Computer Skills:  

  • Must be proficient in MS Office Suite.
  • Strong knowledge of statistical analysis software (i.e. Minitab, Jump, SAS)

Certificates, Licenses, Registrations:  

  • CQE and/or CQA preferred.

Other Skills and Abilities:

  • Strong written and verbal communication skills.
  • Ability to prioritize and multi-task successfully in a fast paced environment.
  • Excellent organizational skills with the ability to handle multiple tasks.
  • Motivated and hard working.
  • Must be able to work well independently and in a team environment.
  • Must be dependable, flexible and available to work overtime and other shifts as needed.

Physical Demands:

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

  • This position requires travel; Average average travel for this position is 20- 25% with some variation based upon the demands of the business imperative.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

  • Must be able to work in a controlled or clean room environment requiring special gowning as needed.
  • Must have the ability to work safely and conscientiously in a manufacturing environment as needed.

*To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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