Advance Quality Engineer at Stryker

Gurugram, Haryana, India

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Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Bachelor's in mechanical or biomedical or Biotech Engineering
Good understanding of Quality Management Systems (ISO 13485, 21 CFR 820)
Minimum 2 to 6 years of relevant work experience
Experience in the NPD process and various phases of new product development
Knowledge of ISO 14971, IEC 62366, 60601-1 family of standards
Good analytical and problem-solving skills (Preferred)
Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams (Preferred)
Expert-level knowledge of current industry standards for New Product Development and risk management practices (Preferred)
Excellent communication and presentation skills (Preferred)
Must have delivered multiple projects in AQE function and understand Risk Management processes in depth (Preferred)

Responsibilities

Primarily responsible for Risk management and risk assessment as per ISO 14971, Risk Table creation & Analysis, FMEAs, Quality Plan, Literature Review, Device Master Record, Quality Training Plan and Technical File
Primary participant in new supplier selection, validation, and contract development
Assists vendors in resolving manufacturing and quality issues as required
Partners with the operations team to develop and maintain a robust internal and external supply chain
Develop procedures for incoming, in-process and final inspections for new product development
Assists/Leads in the trending and analysis of quality data (e.g. complaints, scrap, warranty return rate, etc.) and provides guidance to address issues as appropriate
Authors and reviews procedures to ensure GMP and ISO 13485 compliance and provide inputs for NPDP for adherence to QMS along with good documentation practices
Lead product quality related projects
Supports the business in addressing and solving quality problems
Support process validation programs for new product development
Work with engineering & manufacturing teams to develop robust verification test strategies to ensure product safety and reliability

Skills

Key technologies and capabilities for this role

ISO 14971FMEAISO 1348521 CFR 820Risk ManagementQuality PlanDevice Master RecordSupplier ValidationProcess ValidationIEC 62366IEC 60601-1NPDGMP

Questions & Answers

Common questions about this position

What is the work arrangement for this role?

The position offers hybrid or onsite work flexibility.

What are the basic qualifications required?

Candidates need a Bachelor's in mechanical, biomedical, or Biotech Engineering, good understanding of Quality Management Systems (ISO 13485, 21 CFR 820), minimum 2 to 6 years of relevant work experience, experience in the NPD process, and knowledge of ISO 14971, IEC 62366, 60601-1 standards.

What preferred skills are highlighted for this position?

Preferred qualifications include good analytical and problem-solving skills, ability to work with others in various disciplines and multi-national teams, expert-level knowledge of industry standards for New Product Development and risk management, excellent communication and presentation skills, and experience delivering multiple projects in AQE with in-depth Risk Management knowledge.

How much travel is required in this role?

The role requires up to 20% travel.

What experience makes a strong candidate for this position?

Strong candidates have delivered multiple projects in the AQE function, deep understanding of Risk Management processes, experience in NPD phases, and the ability to work effectively on multi-national teams.

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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