Quality Systems Specialist II

MERCK
Posted on

Type

Mid-level industry position

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The Quality Systems Specialist II provides Quality systems support for the Temecula and Ramona sites, Change Projects, and the Quality Management System; ensures compliance with ISO 9001, ISO 13485, and FDA QSR; prepares Quality system documents and reports as needed for the Temecula and/or Ramona sites.

This role will maintain a compliant Complaint Management system in accordance with the Divisional Quality and Site Quality Management System and applicable ISO 9001, ISO 13485, EN46000 and FDA QSR. Additional responsibilities of this role are; coordination of the site Complaint Management program.  Ensure that complaints are investigated and recorded in compliance with local, divisional, and corporate requirements, serve as the primary investigator for inter-site and external customer complaints and monitor trends, serve in the approval of process and documentation changes and development/improvement projects relating to the Complaint Management program. You will provide metrics and reports to site Supervisor upon request, provide technical support to internal and external customers in the achievement of product quality and, as appropriate, communicates with the site Supervisor any potential product deficiencies, provide Investigative, RCA and CAPA support as identified through the site audit system. This role is responsible for interacting cross-functionally to support Technical and Customer Services/Manufacturing/Production deadlines and product delivery schedules. You will participate in quality improvement projects utilizing Lean, Kaizen, and Six Sigma approach in conjunction with Operations Excellence group to develop improvements, assist in providing support for performing internal quality system audit(s), Design/Development and New Product Introduction/Technical Transfer and/or Engineering programs, write and revise Standard Operating Procedures as needed.  This role will require you to be able to work well in a team environment and have the ability to work and communicate effectively with all areas and levels of the organization. You may be required to perform additional duties as assigned

 

Physical Attributes:

Much of the work will be in a production environment.  The ability to clearly and comfortably view, interpret and process information via a computer monitor for extended periods of time during normal working hours is required.  Some assignments may require extended periods in another plant/office location.  Approximately 5% of travel may be required. 

Vision:  Must be able to meet vision requirements as outlined by standard occupational guidelines

Lifting and moving:  up to 25 lbs

Sitting:  Frequently as required by the process – up to 4 hours at a time

Standing:  Frequently as required by the process

Climbing:  Seldom as required by the process

Kneeling:  Occasionally as required by the process

Stooping:  Occasionally as required by the process

Communication:  Job requires both written and oral skills in communicating with others and receiving instruction

Occupational exposure to blood borne pathogens

Ability to view video display terminal images for extended periods of time (up to 4 hours/day)

 

  • Bachelor’s degree in Life Sciences required.
  • 2 + years’ experience in Quality or Lab Sciences with focus in a Class II or Class III drug manufacturing, medical device, or biologics industry in Quality Assurance or Quality Engineering position.

 

  • Excellent analytical skills.
  • Strong understanding of QSR’s, ISO9001, ISO 13485.
  • Strong experience and understanding of data analysis OR project planning
  • Strong experience in solving problems related to quality system issues, production, customer and/or supplier related concerns.

Job Requisition ID:  198295 Working time model:  full-time

US Disclosure The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.North America Disclosure The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

Nearest Major Market: Riverside Job Segment: Medical, CAPA, Quality Manager, Lean Six Sigma, Quality, Healthcare, Management

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More Information

Posted on

Type

Mid-level industry position

Temecula%2C%20United%20States

Temecula , United States