Quality Engineer 2 at Surmodics

Eden Prairie, Minnesota, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

BS or advanced degree in technical discipline
5+ years overall medical device experience
5+ years’ experience in quality assurance or engineering function
3+ years support of a medical device in a quality engineering function
Understanding of Quality Systems requirements as outlined in CFR820/ISO13485, and be able to communicate true requirements to cross-functional teams
Knowledge of medical device design control waterfall
Experience with utilizing a risk-based approach to quality systems processes
Demonstrated technical expertise and leadership in quality
Strong ability to communicate (written and verbally) within and across disciplines and organizational structures
Strong emotional intelligence to work effectively in a fast-paced, highly-collaborative environment
Self-starter, with the ability to manage multiple tasks and tight timelines
Demonstrated use of Quality tools and methodologies
High attention to detail, organization, and accuracy

Responsibilities

Support materials receiving and inspection activities with Supplier Quality as owner
Ensure quality of produced products by understanding production process and performing/reviewing in-process and finished goods inspections
Review sterilization results for sterile product and addressing any non-conformances, release sterile product
Draft and route a variety of protocols and reports for product, processes, manufacturing events, and equipment changes/activities
Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations)
Support controlled facilities environment by participating in environmental monitoring, calibration, and preventive maintenance activities
Perform equipment qualification for any new and changing equipment requirements
Initiate/support quality system changes that drive consistency and efficiency
Generate and evaluate metrics that are used to identify negative trends and areas for improvement
Maintain oversight of commercial product to ensure safety and traceability
Manage any returned product through inspection and disposition
Assist in field return investigation and the coordination of any necessary field action/market withdraw
May be assigned other responsibilities of the company's quality system

Skills

Key technologies and capabilities for this role

CAPANon-conformancesSupplier QualitySterile Product ReleaseInspectionsEnvironmental MonitoringCalibrationPreventive MaintenanceQuality ProtocolsManufacturing ComplianceAudit Observations

Questions & Answers

Common questions about this position

What qualifications are required for the Quality Engineer 2 position?

Candidates need a BS or advanced degree in a technical discipline, 5+ years overall medical device experience, 5+ years in quality assurance or engineering, and 3+ years supporting a medical device in a quality engineering function, plus understanding of Quality Systems requirements in CFR.

What is the salary for the Quality Engineer 2 role?

This information is not specified in the job description.

Is this Quality Engineer 2 position remote or on-site?

This information is not specified in the job description.

What does the team structure look like for this role at Surmodics?

The role involves key partnerships with Operations, Marketing, Complaints, Supply Chain, Engineering, and other functional experts to ensure product flow and address field inventory.

What makes a strong candidate for the Quality Engineer 2 position?

A strong candidate will have at least 5+ years of medical device experience, including 3+ years in quality engineering support, a technical degree, and knowledge of CFR Quality Systems requirements to handle manufacturing oversight, non-conformances, and process improvements.

Surmodics

Provides components for diagnostics and medical devices

About Surmodics

Surmodics specializes in providing essential components for in vitro diagnostic (IVD) products and advanced coatings for medical devices. Their IVD offerings include a variety of products such as protein stabilizers, diluents, blockers, substrates, and antibodies, which are vital for creating sensitive immunoassays that detect substances in biological samples. Surmodics also develops advanced coatings for medical devices, including lubricious and hemocompatible coatings, and is known for creating the drug delivery coating for the first drug-eluting stent. The company collaborates closely with clients to accelerate product development and commercialization, which helps them meet market demands quickly. Surmodics stands out from competitors through its strong focus on client collaboration and rapid product development, aiming to support the healthcare and biotechnology sectors effectively.

Eden Prairie, MinnesotaHeadquarters

1979Year Founded

$125MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

201-500Employees

Benefits

Performance Bonus

401(k) Company Match

401(k) Retirement Plan

Company Equity

Stock Options

Risks

GTCR acquisition may disrupt operations or client relationships.

Becoming privately held could reduce transparency and investor confidence.

New thrombectomy systems face competition, potentially impacting market share.

Differentiation

Surmodics excels in advanced coatings for medical devices, enhancing device performance.

The company offers a comprehensive range of IVD products for sensitive immunoassays.

Surmodics' expertise in drug-delivery coatings is unmatched, proven by the first drug-eluting stent.

Upsides

Surmodics' acquisition by GTCR could accelerate growth and innovation.

The launch of Pounce Thrombectomy Systems addresses rising peripheral artery disease cases.

Surmodics' SurVeil DCB shows promising results, boosting its vascular intervention portfolio.

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