Quality Engineer

Position is directly responsible for providing ongoing support for Manufacturing. This person facilitates engineering change projects and validation activities for sustaining production products. They will engage in discussions identifying, documenting and reporting quality issues and ensures that each issue is appropriately triaged for continual manufacturability.

Job Overview:

• Quality Engineering is a fast paced, dynamic environment requiring decision making at the strategic and tactical levels. The job requires a highly motivated self-starter with an ability to work with minimal supervision in a team environment.

• This role will serve as a resource to manufacturing to improve product quality, reliability, and process capability.

• This role will facilitate teams in identifying, documenting, assessing, correcting and preventing quality issues using risk analysis and root cause analysis tools. This role will be responsible for quality planning and establishing and maintaining metrics to improve quality system processes, process capability, reliability and quality of products.

Accountabilities:

• Develop and implement reliability analysis, validation and assessment methods to support successful new test fixtures required for successful manufacturing and or sustaining product changes.

• Provide ongoing quality engineering support post product launch. Provide support to sustaining engineering and manufacturing functions for validation planning and transfer activities. Assist teams in determining process validation needs strategies and requirements. Ensure validation programs meet requirements of Parata QMS standards.

• Set operations quality goals for products and their subsystems in the field and measure against progress.

• Maintain a knowledge base of lessons learned to enable continuous improvement.

• Lead, support, and follow through on nonconformance record management including assessment of CAPA determination, root cause identification, corrective action and preventative action implementation and documentation.

• Act as the role model of the quality first culture in everything we do.

• Trend, analyze, and report on quality data to improve product quality and manufacturing process efficiency (first time right); develop recommendations based on data analysis.

• Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion.

Qualifications:

• Bachelor’s degree in Mechanical, Electrical, Reliability Engineering, or related.

• Minimum 6 years’ experience in quality assurance field in a regulated environment

• Minimum 4 years’ experience in either medical device, automotive, or Aerospace manufacturing companies

• Quality Certification preferred (e.g., CQE)

• Knowledge of ISO 9001 QMS

• Experience or certification as Quality system auditor

• Technical skills including robotics manufacturing, complex and large scale electrical system assembly preferred

• Results orientation with strong written and oral communications skills to lead cross-functional teams.

• Ability to effectively lead and influence cross functional teams.

• Strong problem identification and problem solving abilities.