Quality Sr Engineer I

-Requisition Number
AMER28493
Employment Type
Full-time
Location
Bogota

**Job Summary**:
**Principal Duties and Responsibilities**:

- Provides leadership for quality engineering projects on design implementation, testing, documentation, support, and maintenance.- Evaluate process by conducting capability study
- Perform inspection method verification and source inspection of product, as required
- Define the test method validation requirements for material testing
- Evaluate process risk documentations and control documents for acceptance of product and process
- Review and disposition master validation plans, verification and validation protocols
- Initiate and manage changes in the Change Management System Formulates procedures, specifications, requirements and standards for acceptance of Zimmer products and processes.
- Define requirements for internal and external changes impacting supplier processes.
- Identify the requirements for contact materials used by component and subcomponent suppliers
- Define methodology for process verification and validation
- Establish specifications for first article acceptance Provides leadership for quality engineering projects on design implementation, testing, documentation, support, and maintenance.
- Evaluate process by conducting capability study
- Perform inspection method verification and source inspection of product, as required
- Define the test method validation requirements for material testing
- Evaluate process risk documentations and control documents for acceptance of product and process
- Review and disposition master validation plans, verification and validation protocols
- Initiate and manage changes in the Change Management System Develops and implements corrective/preventative action plans
- Perform product and process containment to reduce the risk and impact of the nonconformance - Utilize root cause analysis tools- Develop corrective/preventive actions to address root causes
- Use statistical sampling methods to confirm effectiveness Collects and analyzes data for gauge and product evaluation.
- Perform measurement system analysis (gage R&R)
- Utilize statistical Process Control techniques to evaluate and control processes
- Gather data from ERP system (XA, JDE) to use for evaluation Provides technical support during audits.
- Support frontroom and backroom by producing supporting documents.
- Work with the audit response team in implementing corrective actions and verifying effectiveness. Lead onsite and desktop audits to qualify and re-qualify supplier processes.
- Develop and execute audit plans to verify compliance to standards and regulations.
- Issue corrective actions and follow up on effectiveness
- prepare technical audit reports Ensures that suppliers have necessary information and facilities to deliver quality products to Zimmer.
- Evaluate and disposition nonconformances conditions per medical device industry regulations and quality control procedures
- Function as a liaison between supplier and internal teams to ensure product quality

**Expected Areas of Competence**:

- Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).
- Facilitates team efforts on quality engineering projects.
- Ability to deliver, meet deadlines and have results orientation.
- Able to communicate both orally and in written form to multiple levels of the company.
- Microsoft Office Suite, expert knowledge of blueprint reading and geometric dimensioning and tolerancing, understanding of QSR/ISO regulations, design assurance, FMEA, and product testing methods, and are able to use optical comparators and CMMs.
- Knowledge of statistics, process control, and process capability

**Education/Experience Requirements**:

- B.S. in engineering or an alternative Bachelor’s degree program with certification as a quality engineer (e.g. CQE) required.
- 3-5 years experience required in a Quality Engineering role, or an equivalent combination of education and experience.
- Stated experience must include experience in medical device industry with ISO 13485 and 21 CFR part 820 standards; using verification and validation concepts; using IQ/OQ/PQ in manufacturing, using project management techniques.
- Prefer certification as a quality engineer (e.g. CQE) or the Reliability Engineer Certification (CRE) or Supplier Quality Profession (CSQP) granted through the American Society of Quality (ASQ), or Certified in Project Management (e.g. CAPM, APM).
- Combination of education and experience may be considered (in evaluating experience relative to requirements)

**Travel Requirements**:

- 20%