Apply quality principles, analyzes quality records, prepares reports and recommends improvements.
Conduct inspection, verification and validation of components or materials used in development processes.
Identify and address recurring problems either with the quality of the product or the reliability of testing procedures.
Document quality issues and performance measures for management review.
Interfaces with internal company contacts and external network.
Plans and conducts high level assigned projects within engineering specialty requiring conventional types of plans, investigations, and / or equipment.
Anticipates future directions. Benchmarks internally and externally. Recognizes changes in the environment and present resources as indicators of future problems and opportunities;
prepares for such eventualities.
Independently investigates, conducts tests or experiments, gathers data, and performs preliminary analysis. Reports findings.
Prepares and communicates recommendations and respective action plans.
Predicts patterns / trends. Grasps complexities and sees relationships among data; determines consequences and alternatives;
Mentors others by sharing technical expertise and providing feedback and guidance.
Builds relationships. Initiates and cultivates open, honest relationships with colleagues, customers, contractors, and vendors by establishing rapport, developing an understanding of others’ needs, promoting common goals, and following through on commitments.
Identifies and Evaluates areas of risk with respect to compliance, Product / Mfg performance, Develops procedures, maintain FMEAs.
Resolves problems and provide guidance, such as production process deviations, non-conformances (CAPA), field product performance, urgent out-of-stock replacements, and crisis situations requiring fast, astute decisions with rapid implementation by utilizing technical training and experience.
May work in combination with SQE and Receiving Inspectors focused on driving improvements and CAPA in the quality of components sourced from outside suppliers.
Provides technical support in the supplier corrective action, manufacturing yield and field failures.
Bachelor Degree in Engineering, science or closely related discipline is desired, or equivalent technical.
4 years of experience in medical device or related industries.
Intermediate commands of English (B1) / Required
Desirable availability to work on shift B (Monday to Friday from 3 : 15pm to 10 : 00pm and Saturday from 7 : 00am to 2 : 30pm)
Quality Background desired.
FDA / ISO regulation knowledge.
CQE / CQA / Lean / Six Sigma certification is desired.
Personal skills needed include Leadership, accountability, tact, open-mindedness, maturity, tenacity, decisiveness, self / reliance, scientific thinking, Diligency, Resourcefulness, customer focus.
Capable to persuade and motivate others to improve quality. Effective communication skills.