Development Quality Engineer

******************LOCAL CANDIDATE ONLY And Willing to Relocate As Well****NO C2C CANDIDATES***************

Title: Development Quality Engineer

Location: Saint Paul, MN (Onsite)

Rate: 50k to 55k annually

Position Summary:

Exempt/Non Exempt: non exempt

Years Experience: 2-5

Skills: Verbal and written communication, interpersonal, team work, individual contributor, multi task, strong organizational, advanced computer skills

Education: Bachelor level degree in an Engineering Discipline or other technical field experience

Duties:

• participate in or lead teams in supporting quality disciplines, decisions, and practices

• lead on-time completions of design control deliverables

• support on-time execution of Quality Plans for internal product development process (PDP), OEM-based Clinical Product Development (CPDP) and design change projects

• accountable for generation of PDP design verification test plans/reports for product/system requirements

• lead or support Risk Management activities from product concept through commercialization, including generation of risk management plans/reports, completion and maintenance of hazard analysis, FMECA's and Cybersecurity risk assessments

• lead identification of essential outputs and generate Essential Output reports

• accountable for completion of labeling verification activities and labeling verification reports

• work with design engineering in the completion of customer/system/product requirements

• work with design engineering in the completion of product verification and validation

• endure DHF content completion, integrity and regulatory & standards compliance, collaborative communication resolving gaps

• complete document change request reviews in a timely and objective manner

• identify and implement effective process control systems to support the development, qualification and on-going manufacturing of products to meet or exceed internal and external requirements

• assist in the implementation of assurances, process controls and CAPA systems designed to meet or exceed internal and external requirements

• assist in tech development and execution of streamlined business systems which effectively identify and resolve quality issues

• apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving quality issues

• support all company initiatives as identified by management and in support of quality management systems (QMS), Environmental Management Systems (EMS) and other regulatory requirements

• additional duties may be identified by functional management based on the current project/business objectives.

******************LOCAL CANDIDATE ONLY And Willing to Relocate As Well****NO C2C CANDIDATES***************

Job ID: Sedaa48724

Title: Engineer, Supplier Development Quality

Location: Scarborough, Maine (Onsite)

Rate: 50k to 65k annually

Position Summary:

MAIN PURPOSE OF THE ROLE

Drives supplier quality performance, continuous improvement, and risk mitigation across the supply base. Acts as a key technical contributor partnering across functions to ensure supplier capabilities meet product, regulatory, and business requirements. Leads supplier quality activities and influences outcomes without direct authority.

MAIN RESPONSIBILITIES

• Support onboarding of suppliers, including validation and readiness activities
• Contribute to supplier improvement plans to address performance gaps
• Collaborate with suppliers to improve process capability and product quality
• Track supplier quality metrics (PPM, defect rates, yield, escapes) and perform trend analysis
• Monitor supplier performance and identify risks and systemic issues
• Support supplier reviews and follow-up on improvement actions
• Investigate supplier-related defects, incoming issues, and field failures
• Own supplier nonconformance management, including containment, resolution, and closure of supplier-related issues
• Support root cause analysis and implementation of corrective and preventive actions (CAPA)
• Drive and own supplier corrective actions, ensuring timely and effective implementation and verification of effectiveness
• Communicate supplier quality issues and track resolution progress
• Support development and maintenance of inspection procedures and acceptance criteria
• Assist in optimizing incoming inspection strategies based on risk
• Provide guidance to inspection teams as needed
• Collaborate with Design Engineering, Manufacturing, Procurement, and Quality teams
• Provide input to supplier-related quality decisions
• Participate in cross-functional problem-solving efforts
• Analyze data to identify trends and opportunities for improvement
• Own supplier change management processes, including review, risk assessment, approval, and implementation of supplier-initiated changes

QUALIFICATIONS

EXPERIENCE / BACKGROUND

Supplier Development Quality Engineer responsible for activities related to supplier selection and evaluation, material qualification, supplier performance and receiving inspection. Contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet SJM and regulatory requirements.