Senior Quality System Engineer

SUMMARY

The Quality Engineer II is responsible for supporting the Smith & Nephew Quality Management Systems. The Manufacturing Quality Engineer will ensure that the Regulations, Standards and Guidelines are compli‐ant with ensuring that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (the act).

ESSENTIAL FUNCTIONS

Position Functions % of Position

Develops and works with area teams to implement continuous quality improve‐ment programs/productivity projects which may include: vendor certification for ship to stock; design of experiments to identify and thus control process vari‐ables; elimination of lot inspection and ini‐tiation of process audit activities; and in‐stallation of statistical and non statistical process controls; simplification of forms.

Participate in Design Reviews and identify improvements based past manufacturing experience, and Marketing/Customers’ sp ecifications/requirements for products;

Implement protocols and methods (in‐cluding SOP’s) to ensure that incoming material and manufactured components/products are compliant with internal requirements as well as to standa rds/regulations.

Drive the use of statistical and risk man‐agement techniques for design and man‐ufacturing validation/verification.

Perform analysis of reports and produc‐tion data to identify trends and recom‐mend updates or changes to quality standards and procedures when necessary.

Develop/Use Key Process Indicators to determine process effectiveness, identify areas for improvement, best practices, and drive continuous quality improvement;

Drive corrective, preventive, and closure actions for project issues related to qual‐ity and/or test nonconformance;

Lead the review, disposition, and corrective action activities associated with discrepant components, materials, sub-assemblies and finished products.

Drive and document equipment out of specification investigations .

Provide technical assistance during complaint investigations.

Ensure compliance to product specific standards, cGMP, QSR, US FDA, ISO,

Generate procedures in compliance with internal policies. 80%

Assist the Quality organization during internal/external inspections.10%

Lead continuous improvement activities (CCRs and/or PARs).10%

REQUIREMENTS

Travel

Domestic - Up to 10%

Education

Bachelor's degree in Engineering.

Licenses/Certifications

CQE (desirable)

Process Validation (desirable)

Quality systems regulation (desirable)

Experience

Minimum 2 to 3 years in Medical Device / Biologics/IVD manufacturing experience.

Considerable hands-on experience in Medical Device manufacturing with strong working knowledge of FDA

QSR, IVDD and ISO 13485.

Competencies

Time management, ability to plan and schedule multiple projects and tasks

Collaboration

Interpersonal savvy

Effective written/oral communication skills

Team player

Accountability

Instills trust

Innovation

Negotiation skills

Other

Knows and adheres to the quality policy of the company and the quality-related procedures and instructions

Reports any deviation in product or process, of which he/she becomes aware, to his/her manager or the Quality department

Completes all necessary training in the area of Quality and GMP (Good Manufacturing Practice)

Immediately reports any dissatisfaction or complaint which is brought to their atten‐tion from a customer or patient regarding a Smith & Nephew product (e.g. in terms of quality, durability, reliability, safety or performance) to the complaints department

Complies with all health, safety and envir‐onmental policies, procedures and job hazard analyses applicable to specified job activities; including medical evalu‐ations as required by job function

Completes all required HSE training

Physical Demands:

Weight Lifting: Light (0kg - 5kg)

Position: Mostly sitting

Repetitive Motion: Mostly computer use

Chemical Exposure: Alcohol or cleaning agents only.

Physical Risk (Personal Protective Equipment – PPE): frequent use of PPE required per company policies

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.

Veterans are strongly encouraged to apply