Quality Engineer

SUMMARY: Under the direction of the Quality Director, you will assist in elevating and systematizing engineering and manufacturing processes. Daily activities will require you to proactively identify potential issues to mitigate risk, improve product quality, and assist in delivering corporate strategic initiatives.

REPORTS TO: Director of Quality

WORK AUTHORIZATION: US Person

LOCATION: 1400 Emerson Street, Rochester, NY 14606

REQUIRED KNOWLEDGE & SKILLS:

• Perform data analysis to recognize improvement opportunities.
• Ability to manage internal and external complaints, including identifying root causes and developing corrective and preventive actions.
• Coordinate and support internal and external audits of the QMS to maintain compliance to AS9100 / ISO9001 and ISO 13485 requirements. Provide strategic and detailed planning of audit execution including clear communication, documentation, and timely follow-up.
• Maintain and develop PEKO’s QMS while identifying risks, creating improvement plans, and determining and communicating objectives.
• Develop and improve procedures including providing training when needed to support PEKO’s QMS.
• Advise staff on issues of compliance to industry standards, lead management reviews and coordinate quality communications.
• Manage and support internal and external audits to confirm departmental compliance.
• Support compliance gap management activities e.g., compliance risk management- identifies risks to the division and resolutions to address compliance gaps.
• Lead in the implementation of assurances, process controls, and CAPA related systems designed to meet or exceed internal and external requirements.
• Provide company policies and procedure training as required.

REQUIRED EXPERIENCE & EDUCATION:

• Ability to collaborate and communicate with all stakeholders.
• Proven analytical problem-solving skills in a dynamic environment.
• Demonstrated knowledge of ISO 13485 and AS9100; must be able to establish quality protocols and procedures that align with requirements.
• Previous experience with Six Sigma, Lean Manufacturing, TQM, and/or other continuous improvement methodologies is preferable.
• Experience with creating and/or managing Design History Files (DHF) and Device Master Records (DMR).
• Associate or bachelor’s degree and a minimum of 3 years prior Quality Control experience in the Medical Device Industry.

Compensation:

Individual compensation packages are based on a variety of factors unique to the candidate, including skill set, experience, qualifications, and other job-related reasons. A reasonable estimate of the compensation range for this position is $49,900.00 – $79,100.00 per year.

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PEKO PERKS:

• Competitive Total Rewards
• Tuition Reimbursement (IRS allowable pre-tax max)
• 401K, Medical, Dental, & Vision
• Flexible Spending & Health Savings Accounts
• Life, Short, & Long-Term Disability
• Recognition Awards & Discretionary Benefits

OUR CORE VALUES:

• We care about our talented and loyal PEKO family.
• We are committed to providing a safe, clean, and positive workplace.
• We believe in transparency, honesty, and respect for all stakeholders.
• We are dedicated to maintaining an agile and financially prudent organization.
• We foster the belief that PEKO people are resilient problem-solvers impacting the future.

OTHER:

• This position may require you to follow other job-related instructions and to perform other job-related duties as requested or assigned, subject to all applicable state and federal laws. Duties, responsibilities, and activities may change at any time with or without notice.

PEKO Precision Products, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, and training.

CANDIDATES MAY APPLY BY: submitting our online application via the ‘apply’ button below or by emailing your resume to careers@pekoprecision.com. We welcome all job seekers including minorities, females, veterans, individuals with disabilities, and those of all sexual orientations and gender identities.

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