Sr Quality Hardware Engineer

BELOW THE MUST HAVE:

• Strong Experience with Test Method Validation and MSAs.
  Strong Risk Management Experience (Experience in Risk Documentation: Write, review, approve multiple quality records includes but not limited to: Design Files, Risk Management files, RPM P1 and P2 calculations, Risk Mitigations, etc.)
• Bachelors’ degree in Engineering field. • Minimum of 4+ years of work in medical device industry experience in Engineering, Quality and Supplier Quality OR Advanced degree in Engineering field with 2+ years of work in medical device industry experience in Engineering, Quality and Supplier Quality with Strong Experience in Validation/Qualification activities: (Write, coordinate, execute, create reports, IQ, OQ, PQ, MVPR, Sampling size determination: For Attribute or variable data, Strong statistical background, PPAP review, etc)
• Able to work and perform labor-intensive quality engineering hands-on activities, with minimum of supervision in a hybrid working organization set up • Good writing and documentation skills. • Good organizational and verbal communication skills. • Ability to work in fast-track schedule and meet deliveries on time. • Ability to communicate effectively. • Ability to interact with a very diverse team keeping high ethics standards. • Demonstrate commitment with the company's Core Values.

BELOW THE NICE TO HAVE:

• ASQ Quality Engineer Certification. • Bilingual English/Spanish preferred but not required. • Previous Medical Device experience is helpful. • DMAIC Lean / Six Sigma Certification • Manufacturing experience within a controlled and regulated industry.

Education Required: Yes, Bachelors’ degree in Engineering. Minimum of 4+ years of work in medical device industry experience in Engineering, Quality and Supplier Quality OR Advanced degree in Engineering, with 2+ years of work in medical device industry experience in Engineering, Quality and Supplier Quality with Strong hands on Experience in Risk Management, P1 and P2 calculations, Validation and Qualification activities.

Years’ Experience Required: Minimum 4+ years. My expectation would be 5 – 20+.

Based on the nature of the projects, the responsibilities may include, but not limited, to the following duties.

• Provide Quality Engineering support to multiple projects, uncluding supplier quality engineering support.
• Day to day Risk Management review is anticipated. Strong Risk Management experience is a must.
• Develop, execute, analyze, and report on validations/qualifications activities including but not least: IQ, OQ, PQ, MVP, Test Method Validations to support commercial release product lines.
• Evaluate, review and/or update multiple quality records, including but not limited to: Design files, Process documents, and Risk Management files to be following ISO standards and local procedures.
• Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
• Works directly with operating entities, with multiple functions, internal and external, to provide quality engineering and supplier quality engineering support to assure requirements meet project expectation and meet local procedures and regulations.
• Prepares reports and/or necessary documentation in the project scope, and provides to applicable stakeholders, both internal and external on scheduled expected time.
• Develops, modifies, applies, and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
• Implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment when require.
• Specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to products or materials to meet required standards and specifications.
• Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.
• Will support multiple projects uncluding, but not limited to areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as required.
• Perform detailed Root Cause Investigation of failed product or processes using various quality tools (5 Whys, 6 M, Ishikawa Diagram, Pareto Charts) when require.
• Interface and interact with cross functional team in Production, Manufacturing/Process Engineering, R&D, Regulatory department and other to resolve process issues and implement changes.
• Apply knowledge of process control tools, statistical sampling, and other analytical techniques on the qualification activities to maximize the quality and flow of product through the production line.
• Identify, analyze, and manage risk through product life cycle with use of risk management tools.

DIFFERENTIATING FACTORS

Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.

Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements.

Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking.

Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product .

Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.