Senior Quality Engineer (26 months contract) at Stryker

Arroyo, Puerto Rico, Puerto Rico

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

B.S. in engineering
5+ years experience in Quality Assurance Engineering or related functional area
Knowledge of inspection methods in the design and production of electromechanical and/or mechanical equipment
Strong analytical skills and presentation skills
Effective interpersonal skills
Blueprint/engineering schematic reading and interpretation
Basic inspection techniques
Basic PC skills
Bilingual (English and Spanish)
Sedentary work: Exerting up to 10 lbs. of force occasionally and/or a negligible amount frequently; generally sitting most of the time
Very good visual acuity
Ability to work with and inspect very small objects and/or tools and component parts
Mental: Observe and note minute inconsistencies; generate, follow, and explain detailed instructions and inspection procedures; complete detailed documentation accurately; communicate deficiencies; analyze and resolve non-routine issues using independent judgement

Responsibilities

Continuously comply with all regulatory related requirements
Conduct Internal and External audits
Train others in Quality Assurance/GMP/FDA-QSR related topics
Design and/or implement methods and procedures for inspecting, testing, and evaluating precision and reliability of products, production, and/or test equipment (e.g., Statistical process control, Incoming part/product inspection criteria, Automated testing, Functional gauging, Productivity improvements)
Stop further processing in the event of encountering non-conforming products condition
Design and/or specify inspection and testing mechanisms and equipment
Prepare documentation for inspection/testing procedures
Support vendor management issues: Problem solving, Auditing, Inspection techniques/equipment, Training
Interact with suppliers telephonically or in person to develop and standardize inspection methods/techniques for component compliance
Interact with customers telephonically or in person to solve reliability issues, answer product questions, conduct complaint investigation/problem solving, customer training, design improvements, and special orders
Assist during new product development: Validation support for product, processes, packaging, software, and sterilization
Analyze reports and/or returned products and recommend corrective action
Conduct failure analysis of products and processes: Problem solving, Reliability design improvements, Product failure trending, Training
Work from verbal and/or written instructions
Commit to the EHS policy
Work closely with Operations to resolve in-house and supplier quality problems using established problem solving methodologies (Root Cause Analysis, Mistake Proofing, etc.)
Actively participate and lead on new product development teams to support product and process design and development activities
Lead and participate in the development and improvement of manufacturing processes for existing and new products
Review and approve inspection plans, routers, and product drawings
Lead in development, review, and approval of process and equipment validation/qualifications
Coordinate the activities of one or more Quality Control Inspectors and/or Technicians
Evaluate the performance of one or more Quality Control Inspectors and/or Technicians based on pre-established parameters
Serve as mentor to QA Engineers and/or Associated QA Engineers

Skills

Statistical Process Control

GMP

FDA-QSR

Internal Audits

External Audits

Incoming Inspection

Automated Testing

Functional Gauging

Failure Analysis

Validation

Problem Solving

Vendor Management

Supplier Auditing

Complaint Investigation

Stryker

Develops and manufactures medical devices and equipment

About Stryker

Stryker develops and manufactures medical devices and equipment aimed at improving patient care and surgical efficiency. Their products include surgical tools, neurotechnology devices, and orthopedic implants, which are sold directly to hospitals and clinics. Stryker stands out from competitors by focusing on high-quality products and a commitment to advancing healthcare solutions. The company's goal is to enhance the overall healthcare experience for both patients and medical professionals.

Kalamazoo, MichiganHeadquarters

1941Year Founded

$423.3MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Medical & prescription plans

Supplemental health benefits

Flexible Spending accounts

Employee Assistance Program

Short-term & long-term disability

Tuition reimbursement

401(k) plan

Employee Stock Purchase Plan

Risks

Integration challenges from acquisitions may strain Stryker's resources.

Rapid tech advancements risk obsolescence of Stryker's current products.

Regulatory scrutiny on acquisitions could delay Stryker's market entry.

Differentiation

Stryker's acquisitions enhance its minimally invasive surgical solutions portfolio.

Entry into the peripheral vascular segment diversifies Stryker's market presence.

Stryker's focus on AI integration boosts diagnostic accuracy and operational efficiency.

Upsides

Growing demand for minimally invasive solutions aligns with Stryker's strategic acquisitions.

The orthopedic implants market growth benefits Stryker's expanding product line.

Stryker's acquisition of Inari Medical positions it in a high-growth vascular market.

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