Sr. Quality Specialist (4143)

Job Location
Mansfield, MA
Job Description

The Sr. Quality Specialist works closely with members of the project team to ensure that product development is conducted in compliance with internal and external design control processes. The incumbent provides quality assurance input during the development process. The Sr. Quality Specialist exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.

The Sr. Quality Specialist plays a key role in controlling product from receipt or manufacture through final disposition, supporting complaint investigations, reviewing/approving deviations, reviewing/approving validations, and participating on the Material Review Board (MRB) as required. Reviews and approves change control activities as they relate to Manufacturing Operations. Provides input to procedural changes, technical reports and validations as appropriate. Oversee the metrology program. Responsible for assuring compliance to in-house specifications and cGMP, ISO and other standards as applicable.

The Sr. Quality Specialist must have a solid background in cGMP compliance in support of medical device and/or pharmaceutical manufacturing operations. A working knowledge of cGMP, QSRs, ISO standards, and other applicable regulations is required. The position also requires the ability to: audit procedures, data, and processes, effectively interact with all levels of personnel, multi-task and prioritize activities, and in general have the ability to be flexible.
May serve on cross functional teams to investigate problems and address issues.
Proficient in MS computer applications: Outlook, Word, Excel, others as required.

- Maintenance of the Design History and Risk Management Files for multiple development projects.
- Oversee that documents filed in the Design History and Risk Management Files, are compliant with FDA regulations and ISO standard on design control (21CFR820.30 and ISO 13485:2003) and Risk Management (ISO 14971:2007).
- Provides Quality Assurance input during product development including, but not limited to, establishment of product specifications, definition of DHF document architecture and application of statistical methods.
- Auditing, Change Control, Deviations, CAPAs, SCARS, Complaints, and Validation Review.
- Other duties as may be assigned.

Supervisory Responsibilities:
- None - this is an individual contributor position, but may be called upon to coordinate team activities with other multi-disciplinary team members.


Education and work experience (minimum education level and years of experience required to meet the expectations of the position):
- A BS degree in biochemistry, chemistry, biology, engineering, or a similar field and a minimum of 5 years of relevant experience.
Job related knowledge and skills (minimum levels required to meet the expectations of the position):
- Professional knowledge and experience with FDA regulations and ISO standards for design control (21CFR820.30 and ISO13485:2003) and Risk Management (ISO 14971:2007) of medical devices.
- Experience with Design History and Risk Management File compilation and review.
- Professional experience with device design development: design verification & validation, process validation, design transfer, requirements traceability and design & development planning.
- An understanding of scientific principles and sufficient technical training to evaluate data and challenge conclusions.

Lab equipment and computer experience and level of proficiency (minimum required to meet the expectations of the position):
- Commensurate with experience and education.
- Proficient in MS Office applications including Outlook, WORD, EXCEL, Power Point, and Project.

Communication and language skills (type and frequency of interactions with others as well as any language requirements):
- Good command of the spoken and written English language is required. Must be able to communicate effectively with employees at all levels of the organization through written and oral correspondence, meeting presentations as well as in person. Must be able to provide expertise and guidance to members of the development team.
Mathematical skills:
- Commensurate with experience and education.

Decision making skills:
- Must be able to exercise sound judgment for decision-making responsibilities, particularly in the absence of the supervisor. Must also be able to prioritize responsibilities in a multi-tasking environment.
Physical requirements (i.e. lifting, standing, visual):
- None.

How to Apply

If interested, please apply online at, requisition ID # 4143

About Our Organization

As the innovative market and technology leader, QIAGEN creates sample and assay technologies that enable access to content from any biological sample.

Our mission is to enable our customers to achieve outstanding success and breakthroughs in life sciences, applied testing, pharma, and molecular diagnostics. We thereby make improvements in life possible.

Our commitment to the markets, customers, and patients we serve drives our innovation and leadership in all areas where our sample and assay technologies are required.

The exceptional talent, skill, and passion of our employees are key to QIAGEN’s excellence, success and value.

Students whose classmates are interested in science are more likely to think about a career in science, technology, engineering, and mathematics, a new study says.

CNBC reports that the genetic counseling field is expected to grow as personalized medicine becomes more common.

Gladys Kong writes at Fortune that her STEM background has helped her as a CEO.

Social scientists report that the image of the 'lone scientist' might be deterring US students from STEM careers.