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Company

Original Job Post

BioSpace · 1 week ago

Principal Quality Engineer

Washington, DC

Full-time

Hybrid

Senior Level

7+ years exp

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Comp. & Benefits

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Responsibilities

Ensure program alignment and proper linkages within the Design and Development Plans, Risk Management Documentation, and Control Plans. Provide oversight and review of Human Factors Engineering (HFE) Protocols and Reports, as well as onboarding and auditing HFE suppliers related to life cycle management of commercial programs.

Train and educate key functional partners and management on combination product requirements, standards and regulations

Contribute to content and review of regulatory submissions and RTQs, and support audits and inspections for associated projects related to life cycle management of commercial programs

Scope may include a wide range of products, including but not limited to vial, prefilled syringes, needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, electromechanical on-body injector systems, and accessories.

Plan and lead continuous improvements to the quality processes related to devices, combination product, assembly, labeling and packaging.

Provide independent design review for other programs

Ensure inspection readiness and maintain CE marks for existing combination product devices

Conduct investigations, root cause analyses and risk assessments

Collaborate cross-functionally and with Senior Management to drive improvements and provide backup support to other Quality focus areas

Work in partnership with Combination Product Operations Quality (CPOQ) Leadership to develop business plans that cultivate staff development and support the direction of the business

Benchmark with industry regarding quality and compliance models for devices and combination products

Train and mentor relevant staff for development and succession planning

Qualification

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Doctorate degreeMasters degreeAssociates degreeQuality experienceProgram ManagementQuality ManagementR&DProduction ManagementMedical Device ExpertiseRegulatory ComplianceRisk ManagementQuality ProcessesChange ControlDesign ControlsRoot Cause AnalysisProject ManagementCGxP RegulationsLean Six SigmaMatrixed Team EnvironmentProblem-SolvingLeadershipNegotiationInfluencingCommunicationAnalyticalAdaptabilityPersistenceTeamwork

Required

Doctorate degree and 2 years of Quality experience

Masters degree and 4 years of Quality experience

Bachelors degree and 6 years of Quality experience

Associates degree and 10 years of Quality experience

High school diploma / GED and 12 years of Quality experience

Preferred

Bachelors or Masters degree in Life sciences, Engineering, or related subject area

7 years of professional experience in Program Management, Operational Excellence, Quality, R&D, and/production

Deep medical device/combination product expertise and experience including functional knowledge of applicable guidance, regulations and standards to enable future compliance as projects move through design controls

Subject matter expert in Risk Management for combination products

Deep and broad understanding of quality processes including change control, design controls, risk assessment and management, and root cause analysis

Strong project management skills / ability to lead all aspects of numerous projects simultaneously

Deep understanding of cGxP regulations, practices, and trends pertaining to medical device/combination product quality

Lean six-sigma greenbelt/blackbelt

Demonstrated strong leadership, negotiation and influencing skills along with advanced communication and analytical skills

Effective and timely decision making and influencing skills

Ability to work effectively in global multi-functional teams and in a highly matrixed team environment

Willingness to learn and be persistent

Ability to adapt to changing business needs

Willing and able to travel up to 20%

Benefits

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

Stock-based long-term incentives

Award-winning time-off plans and bi-annual company-wide shutdowns

Flexible work models, including remote work arrangements, where possible